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ortx-8k_20210111.htm
false 0001748907 00-0000000 0001748907 2021-01-11 2021-01-11
Date of Report (Date of earliest event reported): January 11, 2021
ORCHARD THERAPEUTICS PLC
108 Cannon Street
London EC4N 6EU
(Address of Principal Executive Offices; Zip Code)
Registrant's Telephone Number, Including Area Code: +44 (0) 203 808 8286
Symbol(s)
American Depositary Shares, each representing one ordinary share, nominal value £0.10 per share
ORTX
The Nasdaq Global Select Market
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On January 11, 2021, Orchard Therapeutics plc (the "Company") issued a press release announcing a preliminary unaudited estimate of its cash and investments as of December 31, 2020 (the "Financial Information"). A copy of the press release is attached as Exhibit 99.1 to this current report on Form 8-K (the "Report"). The Financial Information is unaudited and does not present all information necessary for an understanding of the Company's financial condition as of December 31, 2020 and its results of operations for the three or twelve months ended December 31, 2020.
The Financial Information contained in Item 2.02 of this Report and Exhibit 99.1 attached hereto shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the "Securities Act"), or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 7.01Regulation FD Disclosure.
The Company intends to participate in the virtual 39th Annual J.P. Morgan Healthcare Conference during the week of January 11, 2021, including holding various investor and analyst meetings and presenting on January 13, 2021 at 9:10 a.m. Eastern Time. A copy of the Company's slide presentation is attached as Exhibit 99.2 to this Report. The Company undertakes no obligation to update, supplement or amend the materials attached hereto as Exhibit 99.2.
The information contained in Item 7.01 of this Report and Exhibit 99.2 attached hereto shall not be deemed "filed" for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 8.01 Other Events.
On January 11, 2021, the Company issued a press release announcing its 2021 strategic priorities. A copy of the press release is attached as Exhibit 99.1 to this Report and is incorporated herein by reference.
Press release dated January 11, 2021
Presentation of Orchard Therapeutics plc
Cover page interactive data file (embedded within the Inline XBRL document)
/s/ Frank E. Thomas
Frank E. Thomas
ortx-ex991_6.htm
Orchard Therapeutics Announces 2021 Corporate Priorities Supporting the Build-out of its Commercial Business in Hematopoietic Stem Cell (HSC) Gene Therapy and Expansion of its Clinical Applications
Preparations on Track for First Half 2021 Commercial Launch of Libmeldy™ (OTL-200), the First Approved Product for Metachromatic Leukodystrophy (MLD) in the EU
Filing Strategy for OTL-200 Biologics License Application (BLA) in MLD in the U.S. to be Communicated by Mid-2021 Following Additional Regulatory Interactions
Marketing Authorization Application (MAA) Filing for OTL-103 in Wiskott-Aldrich Syndrome (WAS) on Track for Year End 2021 in the EU; Followed by BLA Filing in 2022 in the U.S.
New Clinical Data for OTL-203 (for MPS-I) and OTL-201 (for MPS-IIIA) Accepted for Oral Presentation at February 2021 WORLD Symposium; Preclinical Data from Research Programs in Larger Indications Expected in 2021
$192M in Cash and Investments to Support Strategic Execution into the First Half of 2022
BOSTON and LONDON, January 11, 2021 (GLOBE NEWSWIRE) – Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today outlined the company's 2021 strategic priorities in advance of its attendance at the virtual 39th Annual J.P. Morgan Healthcare Conference. These priorities support the company's plan of building a successful commercial business in HSC gene therapy and advancing its portfolio of investigational medicines for high-value, high-need indications.
"In a year that challenged how we live and work, I'm extremely proud of Orchard's achievements in 2020," said Bobby Gaspar, M.D., Ph.D., chief executive officer, Orchard Therapeutics. "Our accomplishments were a direct result of the drive and innovation that fuels our commitment to bring our potentially life-saving HSC therapies to patients, including Libmeldy, which is the first product approved for the treatment of eligible patients with early-onset MLD in the EU. With the HSC approach to gene therapy as our scientific foundation, we are focused on the capabilities that can deliver our therapies on a global commercial scale and support our ability to also treat larger indications over time. It has been a privilege to be a pioneer in changing the way medicine is practiced in these conditions, and we look forward to another year of continued execution and scientific progress."
2021 Corporate Priorities
Orchard has outlined the following key corporate objectives and expected milestones for 2021:
Build a successful commercial business in HSC gene therapy
OTL-200 for MLD:
Launch Libmeldy for the treatment of eligible patients with early-onset MLD in the EU in the first half of 2021.
By mid-2021, complete interactions with the U.S. Food and Drug Administration (FDA) to determine the path to a BLA filing for OTL-200. The company also expects to receive a decision regarding its regenerative medicine advanced therapy (RMAT) designation application for OTL-200 in the first quarter, which, if granted, has the potential to enhance regulatory interactions and open an expedited path to a BLA filing.
OTL-103 for WAS: File an MAA for OTL-103 in the EU by year-end 2021.
Continue to lead the development of gene therapies for neurodegenerative disorders by advancing two proof-of-concept (POC) programs in MPS-I and MPS-IIIA
OTL-203 for MPS-I: Initiate a registrational trial for OTL-203 by year-end 2021.
OTL-201 for MPS-IIIA: Complete enrollment in the five-patient POC trial for OTL-201.
POC trial data: Present clinical data from the OTL-203 and OTL-201 POC trials, including two abstracts that have been accepted for oral presentation at the WORLD Symposium in February 2021.
Investigate the potential of HSC gene therapy in larger indications
Announce new pre-clinical data from research programs in frontotemporal dementia with progranulin mutations (GRN-FTD) and Crohn's disease with mutations in the nucleotide-binding oligomerization domain-containing protein 2 (NOD2-CD) in the second half of 2021.
In preparation for a European launch, Orchard has put in place the commercial infrastructure to support Libmeldy as well as future product launches. The company is qualifying five treatment centers in the UK, Germany, Italy, France and the Netherlands with specialized expertise in transplant and disease area knowledge. In addition, the company expects to leverage cross-border and treatment abroad reimbursement pathways in both Europe and markets such as the Middle East and Turkey. Activities are also underway to drive timely MLD patient identification and access, including disease awareness, genetic testing and newborn screening studies, which have started or are on track to initiate in five countries in 2021.
The company also provided an update concerning the impact of the COVID-19 pandemic on certain development activities. These include restrictions to laboratory access at Orchard and third-party service providers, which is impacting the timeline to develop a specific functional potency assay for OTL-103 in WAS, as requested by the FDA. As a result, the company now expects to file a BLA for OTL-103 in the U.S. in 2022. Orchard is utilizing the benefits provided under OTL-103's RMAT designation and plans to continue interacting with the FDA in 2021 to confirm the data package for the BLA filing. In addition, with several of the follow-up visits associated with the company's active clinical trials impacted by COVID-19 travel restrictions and other trial site limitations, Orchard is using alternative data collection approaches to capture the necessary data to support future regulatory filings.
Frank Thomas, president and chief operating officer continued, "Starting 2021 with a clear set of strategic priorities is crucial to our ability to effectively manage the business while fueling Orchard's continued growth. Our launch preparations for Libmeldy not only mark our evolution towards a fully integrated company but establish a common manufacturing, commercial and operational infrastructure to support multiple future potential products. This work is complemented by our exciting proof-of-concept and research pipeline that we look forward to advancing internally or in partnership."
Key 2020 Achievements
Orchard's key 2020 achievements are highlighted below.
CEO transition and strategy update: Appointed company founder Bobby Gaspar, M.D., Ph.D., as chief executive officer and implemented a new strategic plan to realize the potential of the HSC gene therapy approach.
Libmeldy (OTL-200) EU approval: Received full marketing authorization from the European Commission (EC) for Libmeldy for eligible patients with early-onset MLD.
OTL-200 IND submission: Received FDA clearance for the Investigational New Drug (IND) application for OTL-200 for the treatment of MLD.
OTL-203 in MPS-I: Presented interim data, including clinical outcomes, from the OTL-203 POC trial.
OTL-201 in MPS-IIIA: Dosed the first three patients in the OTL-201 POC trial.
Stable cell line technology: Secured a license for GlaxoSmithKline's proprietary lentiviral stable cell line technology for use in the OTL-103 program in WAS and OTL-300 program in transfusion-dependent beta thalassemia.
New research programs: Announced new research programs in GRN-FTD, NOD2- CD and amyotrophic lateral sclerosis (ALS) at the company's first R&D investor event.
Cash Guidance
The company ended 2020 with approximately $192 million of cash and investments. The company expects that its cash, cash equivalents and marketable securities as of December 31, 2020 will enable the funding of its currently anticipated operating expenses and capital expenditure requirements into the first half of 2022. This excludes the $50 million expected to be available under the company's credit facility and any non-dilutive capital received from potential future partnerships or priority review vouchers.
About Libmeldy / OTL-200
Libmeldy (autologous CD34+ cell enriched population that contains hematopoietic stem and progenitor cells (HSPC) transduced ex vivo using a lentiviral vector encoding the human arylsulfatase-A (ARSA) gene), also known as OTL-200, has been approved by the European Commission for the treatment of MLD in eligible early-onset patients characterized by biallelic mutations in the ARSA gene leading to a reduction of the ARSA enzymatic activity in children with i) late infantile or early juvenile forms, without clinical manifestations of the disease, or ii) the early juvenile form, with early clinical manifestations of the disease, who still have the ability to walk independently and before the onset of cognitive decline. Libmeldy is the first therapy approved for eligible patients with early-onset MLD.
The most common adverse reaction attributed to treatment with Libmeldy was the occurrence of anti-ARSA antibodies. In addition to the risks associated with the gene therapy, treatment with Libmeldy is preceded by other medical interventions, namely bone marrow harvest or peripheral blood mobilization and apheresis, followed by myeloablative conditioning, which carry their own risks. During the clinical studies, the safety profiles of these interventions were consistent with their known safety and tolerability.
For more information about Libmeldy, please see the Summary of Product Characteristics (SmPC) available on the EMA website.
Libmeldy is not approved outside of the European Union, UK, Iceland, Liechtenstein and Norway. OTL-200 is an investigational therapy in the US.
Libmeldy was developed in partnership with the San Raffaele-Telethon Institute for Gene Therapy (SR-Tiget) in Milan, Italy.
About Orchard
Orchard Therapeutics is a global gene therapy leader dedicated to transforming the lives of people affected by rare diseases through the development of innovative, potentially curative gene therapies. Our ex vivo autologous gene therapy approach harnesses the power of genetically modified blood stem cells and seeks to correct the underlying cause of disease in a single administration. In 2018, Orchard acquired GSK's rare disease gene therapy portfolio, which originated from a pioneering collaboration between GSK and the San Raffaele Telethon Institute for Gene Therapy in Milan, Italy. Orchard now has one of the deepest and most advanced gene therapy product candidate pipelines in the industry spanning multiple therapeutic areas where the disease burden on children, families and caregivers is immense and current treatment options are limited or do not exist.
Orchard has its global headquarters in London and U.S. headquarters in Boston. For more information, please visit www.orchard-tx.com, and follow us on Twitter and LinkedIn.
Availability of Other Information About Orchard
Investors and others should note that Orchard communicates with its investors and the public using the company website (www.orchard-tx.com), the investor relations website (ir.orchard-tx.com), and on social media (Twitter and LinkedIn), including but not limited to investor presentations and investor fact sheets, U.S. Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Orchard posts on these channels and websites could be deemed to be material information. As a result, Orchard encourages investors, the media, and others interested in Orchard to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Orchard's investor relations website and may include additional social media channels. The contents of Orchard's website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.
This press release contains certain forward-looking statements about Orchard's strategy, future plans and prospects, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include express or implied statements relating to, among other things, Orchard's business strategy and goals, including its plans and expectations for the commercialization of Libmeldy, the therapeutic potential of Libmeldy (OTL-200) and Orchard's product candidates, including the product candidates referred to in this release, Orchard's expectations regarding its ongoing preclinical and clinical trials, including the timing of enrollment for clinical trials and release of additional preclinical and clinical data, the likelihood that data from clinical trials will be positive and support further clinical development and regulatory approval of Orchard's product candidates, and Orchard's financial condition and cash runway into the first half of 2022. These
statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, many of which are beyond Orchard's control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. In particular, these risks and uncertainties include, without limitation: the risk that prior results, such as signals of safety, activity or durability of effect, observed from clinical trials of Libmeldy will not continue or be repeated in our ongoing or planned clinical trials of Libmeldy, will be insufficient to support regulatory submissions or marketing approval in the US or to maintain marketing approval in the EU, or that long-term adverse safety findings may be discovered; the risk that any one or more of Orchard's product candidates, including the product candidates referred to in this release, will not be approved, successfully developed or commercialized; the risk of cessation or delay of any of Orchard's ongoing or planned clinical trials; the risk that Orchard may not successfully recruit or enroll a sufficient number of patients for its clinical trials; the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical studies or clinical trials will not be replicated or will not continue in ongoing or future studies or trials involving Orchard's product candidates; the delay of any of Orchard's regulatory submissions; the failure to obtain marketing approval from the applicable regulatory authorities for any of Orchard's product candidates or the receipt of restricted marketing approvals; the inability or risk of delays in Orchard's ability to commercialize its product candidates, if approved, or Libmeldy, including the risk that Orchard may not secure adequate pricing or reimbursement to support continued development or commercialization of Libmeldy; the risk that the market opportunity for Libmeldy, or any of Orchard's product candidates, may be lower than estimated; and the severity of the impact of the COVID-19 pandemic on Orchard's business, including on clinical development, its supply chain and commercial programs. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements.
Other risks and uncertainties faced by Orchard include those identified under the heading "Risk Factors" in Orchard's quarterly report on Form 10-Q for the quarter ended September 30, 2020, as filed with the U.S. Securities and Exchange Commission (SEC), as well as subsequent filings and reports filed with the SEC. The forward-looking statements contained in this press release reflect Orchard's views as of the date hereof, and Orchard does not assume and specifically disclaims any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.
Renee Leck
Renee.Leck@orchard-tx.com
Christine Harrison
Vice President, Corporate Affairs
media@orchard-tx.com
2021 JP Morgan Presentation Bobby Gaspar, M.D., Ph.D. Chief executive officer January 13, 2021 Exhibit 99.2
Certain information set forth in this presentation and in statements made orally during this presentation contains "forward-looking statements". Except for statements of historical fact, information contained herein constitutes forward-looking statements and may include, but is not limited to, the Company's expectations regarding: (I) the safety and efficacy of Libmeldy and its product candidates; (II) the expected development of the Company's business and product candidates; (III) the timing of regulatory submissions for approval of its product candidates; (IV) the timing of interactions with regulators and regulatory submissions related to ongoing and new clinical trials for its product candidates; (V) the timing of announcement of preclinical and clinical data for its product candidates and the likelihood that such data will be positive and support further development and regulatory approval of these product candidates; (VI) the timing and likelihood of approval of such product candidates by the applicable regulatory authorities; (VII) the adequacy of the Company's supply chain and ability to commercialize Libmeldy, including the ability to secure adequate pricing and reimbursement to support continued development and commercialization of Libmeldy; (VIII) execution of the Company's vision and growth strategy, including with respect to global growth; (IX) the size and value of potential markets for the Company's product candidates; and (X) projected financial performance and financial condition, including the sufficiency of the Company's cash and cash equivalents to fund operations in future periods and future liquidity, working capital and capital requirements. The words "may," "should," "expects," "intends," "plans," "anticipates," "believes," "estimates," "predicts," "potential," "continue," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements are provided to allow investors the opportunity to understand management's beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are neither promises nor guarantees of future performance. Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which include, without limitation, the severity of the impact of the COVID-19 pandemic on the Company's business, including on preclinical and clinical development and commercial programs, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such forward-looking statements. You are cautioned not to place undue reliance on forward-looking statements. These statements are subject to a variety of risks and uncertainties, many of which are beyond the Company's control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. For additional disclosure regarding these and other risks faced by the Company, see the disclosure contained in the Company's public filings with the U.S. Securities and Exchange Commission (the "SEC"), including in the Company's quarterly report on Form 10-Q filed with the SEC on November 3, 2020, as well as subsequent filings and reports filed with the SEC. These forward-looking statements speak only as of the date of this presentation. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. Forward Looking Statements 2
Curing the incurable The potential of HSC gene therapy
A Vision for Long-term Growth and Value Creation GT, gene therapy 4 TIME VALUE Execute and deliver on rare diseases Build out capabilities in HSC GT across regulatory, manufacturing, commercialization and access Partnership opportunities Focus on HSC GT for larger indications Partnership opportunities Mid-long term Near-mid term
We Are Delivering Now and Building for the Future 5 Foundation Strategic Differentiators Demonstrated Proof Points Growth and Expansion HSC Gene Therapy Platform Approach Scientific & Medical Safety + durability over 160 patients treated Larger indications Clinical efficacy across 6 indications Manufacturing Commercial Validation with Libmeldy™
HSC Gene Therapy Offers a Highly Differentiated Approach 6 Monocyte / Macrophage T cells B cells NK cells Megakaryocyte Erythrocyte Granulocyte Literature references: Alessia Capotondo, Rita Milazzo, Letterio Salvatore Politi, Angelo Quattrini, Alessio Palini, Tiziana Plati, Stefania Merella, Alessandro Nonis, Clelia di Serio, Eugenio Montini, Luigi Naldini, and Alessandra Biffi, PNAS September 11, 2012 109 (37) 15018-15023; https://doi.org/10.1073/pnas.1205858109; Tissue macrophages: heterogeneity and functions, Siamon Gordon and Annette Plüddemann, BMC Biology 2017 15:53, 29 June 2017 Integration Self-renewal
Durability of Response and Safety Demonstrated via Longest Patient Follow-up 7 Patients treated in the development phase, including in clinical trials and under pre-approval access (defined as any form of pre-approval treatment outside of a company-sponsored clinical trial, including, but not limited to, compassionate use, early access, hospital exemption or special license). Data based on in-house data as of November 2020. Data include all patients treated with CD34+ hematopoietic stem cells transduced ex vivo with vector of interest.
Improving the HSC Gene Therapy Manufacturing Process HSPC = Hematopoietic stem and progenitor cell 8
Applying Commercial Strategy to Launch Gene Therapies Globally Leverage for Libmeldy and future launches 9 Enable Patient ID & Diagnostics Multi-pronged diagnostics initiatives and newborn screening in EU and U.S. Expand Geographic Footprint Qualifying leading centers with transplant and disease area experience Establish Global Supply Network Inventory, capacity and logistics of supply Secure Market Access Multi-stakeholder engagement with flexible payment models
HSC Gene Therapy: Meeting the Need in Severe Neurodegenerative Disorders 10
Clinical Efficacy in Multiple Devastating, Rapidly Progressive Diseases 11 LI, late infantile; EJ, early juvenile CI, confidence interval; GMFM, gross motor function measurement; MLD, metachromatic leukodystrophy; Both LI and EJ patients (EJ not shown) achieved a statistically significant difference on the co-primary endpoint of improvement of >10% of the total GMFM score in treated subjects when compared to the Natural History cohort at Year 2, and these were maintained through Year 3. Note: vertical error bars are standard error of the adjusted mean; P-values are from a two-sided 5% hypothesis test with null hypothesis of ≤ 10% difference MPS-I MPS-I MPS-I data presented May 15, 2020 at ASGCT annual meeting
12 New Clinical Data from Three Neurodegenerative Programs Coming at WORLDSymposium™ Nine Orchard Abstracts Accepted Showcasing Strength of HSC Approach
Growing Neurodegenerative Portfolio from Rare to Larger Indications 13 GRN-FTD Research program ALS New research program Discovery pipeline* MPS-I MPS-IIIA MPS-IIIB MPS-IIIB Preclinical MPS-I POC to pivotal 2021 MPS-IIIA Fully enroll POC 2021 MLD Larger neurodegenerative diseases *Other undisclosed development programs EU launch 1H 2021 U.S. IND open
Knopman DS, Roberts RO. J Mol Neurosci. 2011, Onyike CU, Diehl-Schmid J. Int Rev Psychiatry. 2013 and Riedl L, et al Neuropsychiatr Dis Treat. 2014 HSC Gene Therapy Is Highly Suited for GRN-FTD: a Large and Growing Opportunity 14
HSC Gene Therapy: Advancing the Treatment Landscape in Immunological Disorders 15
16 Elimination of severe bleeds OTL-103 for WAS Moderate or severe bleeds Data published January 2020 in Nature Medicine † patient deceased from advanced disease; Excludes data from 1 patient treated with drug product deemed by the investigator to be different from the OTL-102 drug product Functional neutrophils (above 10%) in 6 of 7 patients OTL-102 for X-CGD Oxidase Activity † † Compelling Evidence in Immunological Disorders Data presented at ASH 2019 Events per patient-year of observation for each observation period; GT, gene therapy; mo, months, N, number of patients; Y, years
HSC Transplants Give Rise to Tissue Macrophages with the Potential to Reconstitute Functional Gut Innate Immunity 17
Clinical Validation in X-CGD Supports Application in Larger Populations such as NOD2 Crohn's Disease 18 Proof of concept in rare form of colitis NOD2-CD Research program X-CGD More common forms of colitis
OTL-104 for NOD2-Crohn's Represents a Significant Commercial Opportunity 19 1,2 CD prevalence estimates: Centers for Disease Control and Prevention; European Crohn's and Colitis Organisation (ECCO) 3 NOD2: Ashton, James J et al.Clin Transl Gastroenterol. 2020 Feb
Operations and Upcoming Milestones 20
Today's Roadmap for a Sustainable Future 21 1 YE 2020 cash of $192M Access equity markets following inflection points Supplement with non-dilutive capital 2 Focus on highest value programs Allocate R&D capital for larger indications Stage investments in additional rare disease programs 3 Invest for Growth Maintain Strong Balance Sheet Leverage Partnership Opportunities Evaluate based on disease expertise and commercial footprint Leverage HSC GT platform as engine for new indications
2021 is Rich in Expected Milestones Spanning Development and Commercialization 22 Building a fully integrated company Clinical Regulatory Commercial OTL-204: Announce data from GRN-FTD research program OTL-104: Announce data from NOD2-CD research program OTL-203: Initiate registrational study for MPS-I OTL-201: Complete enrollment in MPS-IIIA POC study Present interim data from OTL-201 and OTL-203 POC studies OTL-200: Determine BLA filing strategy for MLD by mid-2021 OTL-103: Submit MAA filing for WAS by year-end 2021 Libmeldy / OTL-200: Launch in EU 1H 2021 Libmeldy / OTL-200: Leverage cross-border and treatment abroad reimbursement pathways in Europe, Middle East and Turkey
$192M in cash as of YE 2020 and runway into the first half of 2022 Compelling Fundamentals Driving Near and Long-term Growth 23 1x treatment – HSC gene therapy approach offers curative potential Strong clinical track record – over 160 patients treated Clinical validation in rare diseases increases confidence for larger indications now approved for early-onset MLD in the EU


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The ParisLongchamp Brasserie,
a Trip Round the Gourmet Track
The equine equivalent of the Eiffel Tower, the ParisLongchamp Hippodrome now boasts an eponymous brasserie to complement its already wide range of high-class events. The brasserie is an integral part of the modernisation of the institution. Rooted firmly in the 21st century since April 2018 thanks to a successful facelift by the architect Dominique Perrault, the hippodrome is now delighted to welcome into its heart this new living space. A lively and welcoming place, dreamed up by Antoine Ricardou and Clémentine Larroumet of the be-poles studio.Through the ParisLongchamp Brasserie, the whole universe of horse-racing and its rich language comes to life. Set around two separate hubs — the garden, and the restaurant area — the 500m² space has been greatly inspired by the huge, colourful brasseries of Lyon, in particular Georges. With this spirit in mind we can appreciate that distinctive convivial atmosphere that can reign during the races, or during the Sunday lunches to which ParisLongchamp tempts us with its special menu. Speaking of which, local and "seasonal" produce takes pride of place on the menu, which features classic dishes with a deliberately rustic twist in keeping with the local environment. Both inside and out, ParisLongchamp has all it needs to make it that special place in West Paris that we want to keep to ourselves.
Brasserie ParisLongchamp, 2 route des Tribunes, 75016 Paris. Opening times: Wednesday-Thursday, 12noon-3pm and 7pm-10pm. Friday, 12noon to 3pm and 6pm to10pm. Saturday, 12noon to11pm. Sunday, 12noon to 6pm. Telephone reservations on 01 44 30 75 52, or e-mail contact@brasserie-parislongchamp.com
In the tradition of homemade food, the chef offers classics and country and floral creations that reflect the surrounding environment.
Antoine, Clementine, who are you?
We created be-poles with the idea that the brand must be at the centre of everything and that its strength is based on narrative. Clementine has a background in publishing, I'm an architect. We script these stories so that people can enjoy special experiences through brands.
What was the role of be-poles – your design studio – in the renaissance of the ParisLongchamp brasserie?
When the Paris Society team called us, they wanted to create a modular space to host a brasserie and cater for events. Eventually, we decided to divide the project into two parts. On the garden side, to the left of the entrance, there is a multi-purpose area for celebrations, and on the other side a popular dining area for gamblers and racing fans. It faces the presentation ring for the horses.
Why did you say yes to this project? What was so seductive about it?
Antoine & Clémentine
The 500 m² open space immediately reminded us of the huge brasseries in Lyon. Unpretentious places, furnished with tables and a bar for serving. We had in mind the Brasserie Georges in Lyon, which is, for us, a model of organisation. Here, we needed to create a functional place for fast service. This space was perfect for bringing this approach to life while still preserving its roots.
How did you plan the decoration of this unique place? How did you arrange the areas in the room and their different atmospheres?
Railway station brasserie or racecourse brasserie: they share the same organisational criteria. We needed four different focal points: an entrance lobby where you can read or drink coffee while you are waiting; high tables to lean on and watch the results of the races while also being able to go and see the horses in the parade ring; a bar where you can order quickly before going off to the stands; and finally tables for banquets for punters or just for a lunch between enthusiasts. We pay attention to where we are busiest, to when we need to serve lots of people in a hurry or we have enthusiasts taking their time. Chairs are moved, tables are repositioned.
What were your main inspirations? Why did you choose this particular palette of colours?
The first image in our design notebook was a painting by Jean Béraud painted around 1889. In it, you see a woman sitting at a desk writing in the atmosphere of a large brasserie. Then came the Degas "studies of riders" drawings. These are riding poses. The tones of these drawings led our research. They have it all. The layers, the beiges, the creams, etc. Finally, we explored the world of equestrian saddlery. The inverted leathers placed on the bodies of muscular horses have given our design the rounded edges we needed in this world of straight lines. We also wanted to keep a strong connection with the garden and this famous parade ring. It is all the work of landscape gardener Gwenaëlle Grandjean who has worked on an indoor/outdoor planting so you can enjoy the greenery in both summer and winter. Plants inhabit the hat racks and shelves to create visual breaks in this huge space.
Where do the accessories, paintings and other photographs that fill the spaces come from?
Paris Society gave us access to the archives of France Galop. We were able to display treasures that were tucked away in their archives. Priceless pieces that can be admired at last. Two centuries of horse racing history can finally be admired in ParisLongChamp.
And these large velvet benches, what do they say about the ParisLongchamp brasserie?
The large waiting bench in the middle of the entrance, we wanted it deliberately coloured to echo the jockeys' outfits and the many colours in this equestrian world. The other colours are found on the menus and menus.
What's on the menu, what types of products can we enjoy on this massive terrace?
On the plate, the ParisLongchamp brasserie showcases fresh produce through seasonal, local cuisine prepared from 100% organic fruit and vegetables. In the tradition of homemade food, the chef offers classics and country and floral creations that reflect the surrounding environment. Roast chicken, grilled whole sea bass and leg of lamb are there for you to enjoy with friends. There is a generous menu of dishes to share on Sundays (except on race days).
For you, the ParisLongchamp brasserie, who is it for?
It's for everyone who wants to spend a day in the countryside with their families and children. Have lunch on the grass and go and see the races. Place your bets while you have a drink or a bite to eat. It is also the ideal location for the pro gamblers who have made it their base camp. Personally, I stop there on my bike when I go to Longchamp!
We wanted to keep a strong connection with the garden and the famous parade ring. This is all the work of landscape gardener Gwenaëlle Grandjean.
Photography: Eve Campestrini – Text: Caroline Balvay @thesocialitefamily
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What do you do when you think you are done digging for strength, done trying to think everything will be ok and when you are so angry that you can't even properly place all of the emotions that you are feeling? You absolutely have NO choice and you keep digging deeper… through the fear, anger, sadness and frustration you just look for that something … maybe you did not know you had it…maybe it only comes out when you so desperately need it and maybe you really don't have it but as you pretend, you start to believe the face behind that false bravery and you hope that maybe that is the person you will turn into.
I never imagined that I would have so many challenges from so early on in my life…having so many times where I had to dig deep to love, to forgive and to accept that there were many things that I just could not change. Every time I went through a new challenge I would think…ok what did I learn from that and how can it make me a better person. I do wonder how two robberies in three months in two different homes can actually help me learn something but I am just trying to think there has to be a reason there. I am (soon to be was) a very sensitive person but as I have witnessed in the last almost year, life changes you. For me it's a good thing to not be so sensitive anymore…why was I ever so worried what anyone thought of me, my feelings or my goofy fun times with my kids when I definitely don't act my age. (I will break and say that my Eric needs to learn to chill out) I think I embarrassed him more than once on the train in Milan and he was so concerned about what people thought. Gosh, I hope I can teach him that these things are so unimportant in the grand scheme of things.
From challenges come growth, change and a lot of swear words. As today is our 36th day in the hospital (Although I should not say OUR because it is only Eli's 36th day here) the language barrier might be one of the biggest challenges here, so… I am hoping to know more Italian when I come back with Ella in a few short months. We have ordered a few wrong meals, gotten some mean faces and spent quite a bit of extra time trying to figure out how to flush a toilet. We have tried to figure out the grocery stores, the subway/bus and even more importantly the hours that things are open here. It is not like America where so many people are overworked and never take a break. Sundays are a day of rest (along with most stores taking a break every day for an hour or two in the middle of the day) It is definitely a lifestyle that would not take much to get used to. On to the biggest challenge I could ever imagine…the hospital!
It is interesting how I thought that chemotherapy would be the biggest challenge …putting that poison into my child hoping it will allow for new marrow to grow and hopefully save his life or prolong it. I thought he would be sick and have all the nasty side effects that I had dreaded since the thought of chemo entered my mind. From the first to the last infusion it was hard to watch but aside from some nausea it was not too bad. (The anti-seizure drugs I would like to forget as he was so mean) About 10 days after chemo the mouth pain started with one sore and a sore throat. UGH… I had hoped he would stay clear from mucositis but no matter how many mouthwashes we made him do he still got it… although I know it could have been much worse. He stopped eating completely and the sores got worse covering the whole inside of his mouth. A side effect from this is a constant drool. For about five days the drool would just pour out and whoever was with him would be wiping his mouth every two minutes. He could not swallow and he could not spit. My heart was broken for him. He was on liquid nutrition and not talking from the pain. As his sores slowly started to get better they started weaning him off of the nutrition so he could eat. This is by far the biggest job anyone has who is with him. Every ML of liquid has to be written down, every tinkle has to be saved to make sure he is getting enough fluid. Eli has always been my picky eater, my challenging child and my unbelievable stubborn little man. The qualities may serve him well as he gets older but here… not so much! Every five to ten minutes you put a cup up to his mouth where he drinks maybe a sip to only put it back down. You fight with him over the next hour to get maybe 75ML's down (if we are lucky). Food has the same effect on Eli…it comes in the room and he is not hungry…you pick a piece of chicken apart for him to eat five bites over an hour all the while being angry because he just does not want to eat. He can have pizza now once a week and that has been a huge help!! You watch him, beg him to eat, then he gets on the scale and you watch the numbers praying that he has not lost any more weight. Just tonight as I was trying to get him to eat he started yelling at me that this is my entire fault. I am the one who made him come here and I am the one who thought that he was weak and needed to get stronger by coming to Milan and getting lots of needles. Yes some tell me be grateful he can show me his true feelings and I am but it is not easy. When I need it I take a break and have a little OR BIG cry in the bathroom and just keep on keeping on.
I don't think any of us see ourselves for who we truly are or maybe we don't want to believe we can be so much better than what we are. I never in a million years thought that I needed to contemplate life more than I did before MLD …yes I was one of THOSE people…always wondering what my plan was, why I was here, knowing that my main goal was how can I make a difference in the life of children. Now I sit in the hospital and contemplate once again but this time there is silence…I feel nothing… I feel like God is a distant memory of when I believed that he gave me these amazing children to let them feel so much love and so much happiness from their mother…and to let me break the cycle of my own sorrow and demons from my years growing up.
As the sadness sometimes is so much to bear…being so far from home and watching Eli be so brave when there is nothing I can do. Worrying about going through this with Ella…living here again…being away from the boys. I feel alone but maybe it is ME that is shutting myself off from God. Right as I was about to publish this blog I got an e-mail from a friend that made me realize God won't let me go that far from him without trying to bring me back in where I need to be. Thank you Alyssa for showing me that God is still here and he showed me tonight through you… I guess I will keep digging.
~ by my4foures on July 8, 2013.


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One of the hardest things that I find when I talk to a beautiful woman is that they are always on guard.
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It is your job as a Don Juan to project yourself in such a way that they feel comfortable enough to reveal themselves to you.
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If you are accepting of their true personality, they will love you for it. The best way that I have found to get women to open up to me is to tell them that I am an extremely intuitive person.
After a few minutes of light fluff talk, I work it into the conversation that I am very good at seeing a person for who they truly are rather than the image that they try to give off to everyone. Once they hear this, the first question they always hod is "What can you tell about me?
Most guys would say something cheesy like they are beautiful or sexy or something else they have heard a million times. The key is to tell them about the person who you think they really are.
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At this point, gaze directly into their eyes with a very curious expression.
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After about five or six seconds start into your rap. Every woman girll that they are a sensitive and caring human. I find most of them really are if you allow them to be. Tell them that you can tell that they are a sensitive person and you can see a real sweetheart inside of.
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Tell them that they are frustrated because all of the nice guys who they talk to just how to make a girl open up do anything for them while the men that they desire do not treat them like they feel that they should be treated. This story applies to every single woman on the planet but they think you're a genius because you could tell that about them specifically. This is the part that will seal the deal. After you tell her these other things, start acting in a manor that tells her you almost feel bad about telling her the next.
You might even ask again for her not to get mad at you. Tell her that you can sense that she often puts walls up around. She sometimes feels like she is an outsider to the world or on an island all by adult arcade denver.
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Who hasn't felt on the outside, or guarded, or that they sometimes can't connect well with certain people. Everyone feels like this but when you tell it to a specific woman, it's like you're looking directly into her soul and assuring her that you like what you see. When how to make a girl open up feel like this, they will tell you everything you could possibly want to know including ti to get her into the sac.
This also works exceptionally well with very beautiful women because they are looked at as a piece of meat by men all the time. It is rare for them to find a man who can understand what it is like to be an attractive woman.
A final note: If you sound like you are spewing out lines that you read somewhere, she will blow you off like every other butthole who talks to. But if you can come across like you truly are sensing that she is a wonderful person, she will want to be with you.
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The Republic of Indonesia draft Law Number 17 Year 2011 on State Intelligence (2011)
On 01/01/2011 in
The draft law contains an introduction and the following sections
General Provisions (Articles 1-3)
Roles, Objectives, Functions and Scope (Articles 4-7)
State Intelligence Management (Articles 8-15)
State Intelligence Personnel (Articles 16-24)
Confidentiality of Intelligence (Articles 25-26)
The State Intelligence Agency (Articles 27-37)
Coordination of State Intelligence (Articles (38-40)
Funding, Accountability and Oversight (Articles 41-43)
Penalty Provisions (Articles 44-47)
Closing Provisions (Articles 48-50)
The draft text is followed by an Explanation of 18 pages that provides a background to the draft Law, with a general introduction and an article-by-article explanation.
Indonesia-intelligence law-draft-2011-eng (full text in English, PDF)
Prakas on Anti-Money Laundering and Combating the Financing of Terrorism relating to All Reporting Entities not regulated by the National Bank of Cambodia
Terrorist Financing Suppression Act of 2011
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Indonesia Law on the Commission for the Eradication of Criminal Acts of Corruption (Law No. 30 of 2002)
Indonesia Bank Regulation No. 4/8/PBI/2002 Concerning Requirements and Procedure for Carrying Rupiah Currency out of or into the Customs Territory of the Republic of Indonesia (2002)
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Bank Indonesia Regulation Concerning Second Amendment to Regulation Concerning Application of Know your Customer Principles (2001)
Bank Indonesia Regulation Concerning Amendment to Regulation Concerning Application of Know your Customer Principles (2001)
Anti-Terrorism Law No. 15 (2003)
1945 Constitution of the Republic of Indonesia (1945, 2002)
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In 1982, Congress enacted the Foreign Antitrust Trade Improvements Act (FTAIA) to resolve uncertainties about the international reach and effect of U.S. antitrust laws. Unfortunately, the FTAIA has provided more questions than answers. It has been ten years since the Supreme Court most recently interpreted the FTAIA, and crucial questions and circuit splits abound. One of these questions is how to understand the convergence of the direct purchaser rule (frequently referred to as the Illinois Brick doctrine) and the FTAIA. Under the direct purchaser rule, only those who purchase directly from antitrust violators are typically permitted to sue under section 4 of the Clayton Act for treble damages. There are several court-created exceptions to this rule that allow indirect purchasers to sue under section 4. This Note addresses the open question of whether courts should apply these exceptions in the FTAIA context. The Seventh Circuit recently discussed this question in Motorola Mobility LLC v. AU Optronics Corp., implying that courts should not recognize Illinois Brick's exceptions in the FTAIA context. This Note argues for a different interpretation of the case—one that supports the effective deterrence of antitrust violations while vindicating the need to compensate American consumers who are foreseeably, substantially, and directly damaged by foreign anticompetitive conduct. Based on an analysis of the purpose of the Illinois Brick doctrine and the text of the FTAIA, this Note concludes that when an exception to Illinois Brick would permit indirect purchasers to sue in the domestic context, U.S. courts should also allow indirect purchasers to sue under the FTAIA.
Jennifer Fischell, Standing in the Way of the FTAIA: Exceptional Applications of Illinois Brick, 114 Mich. L. Rev. 309 (2015).


National property developer FWJK has secured land in Menlyn to develop a new R1.9 billion sectional title mixed-use building. Spanning 85 000m² and consisting of ground and first floor retail, the development will host a 450 learner creche, multi-tenant sectional title office suites, residential apartments and luxury penthouse suites.
Dubbed 'Menlyn Link', the development will be situated between the 177 000m² Menlyn Park Shopping Centre and the Menlyn Maine Central Square Precinct on Lois Avenue. Menlyn Link will assume the mantle of the tallest building in the greater Menlyn area at an impressive 26 storeys, changing the Menlyn skyline and offering 360 degree views of the surrounding vista.
"Menlyn Link offers a range of one, two, three and four bedroom apartments as well as five bedroom penthouses. The apartments are designed to be highly desirable with gas stoves, green technology, spacious living areas and entertainment balconies. With the convenient ground floor shops and restaurants providing a vibrant retail experience together with the rooftop club house, tennis court and swimming pool, residents will have various desirable amenities at hand to name a few. Those working in the P-Grade office suites will truly experience a first of its kind in Menlyn with a 'work-play-live' lifestyle" says Rhys Rocke, regional director of FWJK.
Hugo Moller, a Knight Frank property broker who specialises in the Pretoria region confirmed Rocke's sentiments and added that the Menlyn Precinct is a notable attraction for residents as it is Africa's first green city; being pedestrian and bicycle friendly. Moller went on to highlight the accessibility of Menlyn including the existing BRT routes, Gautrain bus routes and recently upgraded Atterbury and Garsfontein offramps which service the precinct.
Rocke went on say that the development will be undertaken on the basis of the FWJK Co-Development at Cost Methodology giving investors the opportunity to partake in owning equity in the project at the brick and mortar cost which is roughly 30% below market prices.
FWJK expects to launch Menlyn Link to the market in early 2018 with confidence that it will sell out rapidly given high demand peaking in this area.


Last weekend my boyfriend and I took an exceptionally lovely trip to Brier Island. Brier Island is a tiny island in the Bay of Fundy, the westernmost part of Nova Scotia, Canada. This tiny island is only one village large, approximately 25 km in length, and about 200 people live there year-round. However, it's also an exceptional place to go whale-watching, and I have wanted to go for years.
While some people will make a day trip just for to whale watch on Brier Island–it's about 3 hours one way from where I live–we decided to make a whole weekend of it and headed out Friday morning to Sunday morning. Similar to our Cape Breton trip last fall, I decided to round up a summary of our visit in mostly chronological order by sharing all the things you can do when you visit Brier Island!
I've also decided that every food/travel post I do in the future I will make sure to specifically mention access to gluten-free options. I have celiac disease and this is definitely something I look for when traveling so hopefully I can help out somebody else with the same struggle.
After arriving for a ferry just as it was pulling away, followed by a 2+ hour broken ferry delay, we were pretty hungry by the time we arrived on Brier Island around 4 in the afternoon on Friday. There are really only two places to eat on the Island itself and the only one open was the Lighthouse Cafe. Luckily, it still serves tasty, fairly affordable food including their signature Grand Passage Burger. This half pound burger is layered with bacon, cheese, lettuce, tomato, onion rings and mayo. It also comes in a homemade bun. My boyfriend tried it out without a few of those items and enjoyed it–we were really hungry–but wished the bun had been toasted.
I was looking forward to eating lots of seafood on this trip, but unfortunately all the seafood at the Lighthouse Cafe is breaded. Luckily, although they didn't have an actual gluten-free option (they do have a veggie burger though!) they were super accommodating at letting me know which menu items were safe. It was suggested I order a grilled chicken breast or hamburger, so I went with the hamburger option. The sides were all breaded or fried, so not celiac safe, but they were happy to make me a salad (not actually on the menu). The food was really good, and while it's always easiest to travel somewhere where gluten-free is clearly labelled, I was really impressed by the lovely service and accommodation they made for my dietary restriction.
I also tried out a smoothie at lunch the next day, and the only ingredients are fruit, juice, and ice (with the option of adding yoghurt). I went with the pineapple option and while it's not a meal on its own, it is delicious and refreshing!
After lunch we ended up falling asleep for a nap and by the time we woke up the sun was already starting to set. We found our way to the Western Lighthouse which is the perfect place to watch the sunset, but I'll admit we took a few wrong turns before we got there. Luckily the island is only 25 km long! We saw the beginning of the sunset from the car, but I managed a few snapshots as we watched from the beach and it was beautiful. You definitely want to make it to this end of the island to watch the sunset at night.
Bonus! We got a chance to see a Harvest Moon (poorly captured by my iPhone) on our first night there, September 16th, rising into the sky just as the sun was setting. Though hard to plan for, it was very beautiful and we were lucky to see it.
There are a few options of where to stay on Brier Island, but by far the largest/most well-known is the Brier Island Lodge. The Lodge has package deals with the whale-watching companies making it easy to book a night away and save a few dollars at the same time. Plus, if you add on an extra night like we did, it's at a discounted rate. There are plenty of oceanview rooms available, and we stayed in one with a king-sized bed. It's not a super fancy room, but there's a convenient mini-fridge–you'll want to pack some food for snacks since there's only one small store on the island–and a table and chairs right by the large window. I read a whole book while I was visiting sitting at that table and enjoying the view!
In addition to be a great place to stay, Brier Island Lodge offers the second eating option on the island. We went for two breakfasts and one supper there. There's a pretty diverse menu and although it's on the slightly pricier end (~$10 for breakfast and ~$17-30 for supper) it's delicious food with great service in a remote area where everything is transported by ferry…so definitely worth the cost.
For supper on Saturday night I was desperately craving fresh Digby scallops, and luckily I was able to have them. Although usually coated in flour, Ben let the kitchen know of my allergy and they cooked them in foil instead. It was also served with vegetables, which were okay, but there is also a salad option I'd probably go for next time. The salad is more affordable but when I learned this had more scallops…I couldn't resist. My boyfriend ate fish and chips which looked amazing and I didn't get a photo because he dug in right away. He said it may have been the best he ever tried, and he's lived in the Maritimes his whole life. Even the coleslaw was amazing! Plus, when the kitchen ran out of tartar sauce, our waiter went and made some from scratch.
I was definitely content after supper, but when I learned there was a gluten-free dessert option, I had to try it. It was a rum and raisin rice pudding, and although I'd never tried rice pudding before I quickly became a convert. It was really delicious and everything is made fresh there. My boyfriend had their mango and white chocolate cheesecake which was also amazing!
I would highly recommend Brier Island Lodge if you have celiac disease, or another dietary restriction, the staff is extremely flexible and accommodating, and the food is delicious.
Whale watching was the whole reason we came to Brier Island, and it did not disappoint. We booked our tour on the Zodiac, which is a small boat that requires that you wear a full-body flotation suit and only accommodates 12 people. You can see how close to the whales we were able to get! I also took a photo of the Mega Nova, which is a larger boat that has a washroom on it and is better suited to young children, the elderly, etc. However if you are up for a bit of an adventure, I highly recommend taking a ride on the Zodiac!
Even though it was mid-September we had absolutely beautiful sunny weather, and it was perfect whale-watching conditions. Our captain, Jaime, did an excellent job and we hardly went a minute without seeing a whale. We were super fortunate because we saw an orca, or killer whale. This was the first time Jaime had seen one this year, and we heard that the captain on the Mega Nova hadn't seen one in four years! The orca, Old Tom, travels with a posse of dolphins, and you could always tell when he was going to come up by seeing a bunch of them rise up first. It was so cool!
Although we were really spoiled to see an orca, we did also see a finback whale (also rare) and plenty of humpback whales, which is generally what people see. Plus we got awfully close to a seal. It was an amazing time. We were out in the boat about 2.5 hours, but the time will vary depending on the time of year. We really want to go back next year, and we are thinking of booking two whale-watching tours when we do. This is an incredible experience and honestly, it would have been awesome to go out again in the afternoon. Apparently Old Tom breeched later in the day!
In addition to whale-watching, I had heard a lot about Seal Cove before visiting Brier Island. It's a great place to see seals suntanning themselves, and the best time to go is low tide. We went about 30 minutes before low tide and when we arrived another couple let us know we would hear the seals before we saw them. They weren't kidding! There were about 50 seals there and they were so cute to see and hear. You aren't super close to them–my camera zoom does help, but you can have a better idea in the photo I'm in–so I recommend bringing a pair of binoculars. There are also lots of opportunities for bird watching, which we didn't do, but binoculars would help with! After Seal Cove we headed back to the lodge for our supper and a relaxing evening.
Bonus! We didn't actually do this, but I wish we did!
I've messed up the chronological order here, but we actually went to Pond Cove right after lunch, prior to visiting Seal Cove, since we had time before low tide. As soon as we arrived at Pond Cove I wished I'd packed a picnic lunch, and when we go back next year that's absolutely what I'll be doing! It's a beautiful sandy beach, so definitely pack a bathing suit if you want to dip in the ocean–a dad and two kids did while we were there–but we just enjoyed the ocean scent and noises while we relaxed on the rocks.
Bonus! This isn't actually on Brier Island, but it's nearby and worth the visit!
Although not actually on Brier Island, the Balancing Rock is an easy stop on your way back to the mainland. There are two ferries to get to Brier Island, and after the first one you reach reach Long Island where Tiverton and the Balancing Rock is located. The trail to the Balancing Rock takes about 20 minutes, and although online sources vary seems to be a little over a kilometre long. However at the end of that is 250 stairs! So while it's not a difficult hike keep that in mind if you have physical health issues or young children.
There is plenty of information along the hike about the surrounding area as well as the Balancing Rock, and once you arrive it is absolutely worth the view. It's a beautiful area and it is an amazing feat of nature to see that rock balancing!
After visiting the Balancing Rock on Sunday morning we drove back home and got back to our real lives sadly. However this weekend escape to Brier Island was an amazing trip and with so many awesome things to do, I highly recommend you visit the Island if you have the opportunity! Have I sold you on taking a trip to Brier Island yet? Let me know what you think of this travel post, I definitely want to continue to share gorgeous little bits of Nova Scotia when I get the chance. It's such a beautiful place and I'm so lucky to live here.


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power Apr. 5, 2019
All the Women Who Have Spoken Out Against Joe Biden
By Amanda Arnold@aMandolinz
Joe Biden. Photo: Bastiaan Slabbers/NurPhoto via Getty Images
Ahead of former vice-president Joe Biden's expected 2020 presidential bid, women are speaking out about their personal interactions with him — alleging he physically touched them in ways that made them feel uncomfortable. Last week, the Cut published an essay by Lucy Flores, a former Nevada lieutenant governor nominee, who wrote that Biden smelled her hair and kissed the back of her head at a campaign event in 2014. In the week since, several more women have come forward.
Below, here's a running list of the allegations against Biden.
Lucy Flores
On March 29, in the aforementioned essay published on the Cut, former Nevada lieutenant governor nominee Lucy Flores alleged that Biden smelled her hair and gave her "a big slow kiss" on the back of her head at an event for her 2014 campaign. In that moment, she wrote, she felt "embarrassed" and "shocked."
"I wanted nothing more than to get Biden away from me," she continued. In response to the essay, Biden claimed that he had no memory of having "acted inappropriately," but added that if he was in the wrong, he would "listen respectfully."
Amy Lappos
When Amy Lappos was a congressional aide for U.S. representative Jim Himes in 2009, she claims that Biden touched and rubbed his nose against hers during a political fund-raiser. "It wasn't sexual, but he did grab me by the head," she told Hartford Courant on April 1. "He put his hand around my neck and pulled me in to rub noses with me. When he was pulling me in, I thought he was going to kiss me on the mouth."
After the incident, Lappos didn't file a formal complaint. "He was the vice president," she told the Courant. "I was a nobody."
D.J. Hill
D.J. Hill was one of two women to come forward with allegations in the New York Times, which referred to Biden's conduct as "tactile politics" in a report published on April 2. At a 2012 at a fundraising event in Minneapolis, Hill alleges that Biden rested his hand on her shoulder, and then started to move it down her back, which left her feeling "very uncomfortable."
"Only he knows his intent," she told the Times, adding, "If something makes you feel uncomfortable, you have to feel able to say it."
Caitlyn Caruso
In the same Times report, a woman named Caitlyn Caruso claimed that after sharing the story of her sexual assault at a University of Nevada event in 2016, Biden hugged her "just a little bit too long" and laid his hand on her thigh.
"It doesn't even really cross your mind that such a person would dare perpetuate harm like that," she told the Times. "These are supposed to be people you can trust."
Ally Coll
On April 3, Ally Coll told the Washington Post that at a 2008 reception, Biden squeezed her shoulders, complimented her smile, and held her "for a beat too long." A young Democratic staffer at the time, Coll said her initial reaction was to shrug it off. But she told the Post she now feels the alleged incident was inappropriate, adding, "There's been a lack of understanding about the way that power can turn something that might seem innocuous into something that can make somebody feel uncomfortable."
Sofie Karasek
In 2016, Sofie Karasek was photographed holding hands and touching foreheads with Biden at the Oscars, where she stood alongside 50 other sexual-assault survivors during Lady Gaga's performance. It was a moment that soon went viral, and was described then by the Post as "powerful." But in the Post's report published this week, Karasek says she believes that Biden violated her personal space. She also told the Post that she wasn't impressed with Biden's two-minute-long video response to the growing unwanted-touching allegations against him — in which he never says he's sorry — as he "didn't take ownership in the way that he needs to."
"He emphasized that he wants to connect with people and, of course, that's important," she told the publication. "But again, all of our interactions and friendships are a two-way street … Too often it doesn't matter how the woman feels about it or they just assume that they're fine with it."
Vail Kohnert-Yount
In the same Post report, Vail Kohnert-Yount alleged that when she was a White House intern in the spring of 2013, Biden "put his hand on the back of [her] head and pressed his forehead to [her] forehead" when he introduced himself, and that he called her a "pretty girl." She was "so shocked," she said, "that it was hard to focus on what he was saying." Though she told the Post that she doesn't believe Biden's conduct constituted sexual misconduct, she described it as "the kind of inappropriate behavior that makes many women feel uncomfortable and unequal in the workplace."
Alexandra Tara Reade
Alexandra Tara Reade told the Union that Biden touched her several times when she worked in his U.S. Senate office in 1993. The incidents, in which she said Biden would "put his hand on my shoulder and run his finger up my neck," allegedly occurred when she was in her mid-20s. Reade told the Union that her responsibilities at work were reduced after she refused to serve drinks at an event — a task she believes she was assigned because Biden liked her legs.
Reade reportedly spoke to U.S. Senate personnel about what was going on, and Biden's office allegedly found out. She left his office two months later, after only nine months on the job. Reade told the Union that she didn't feel sexualized by the way she'd been treated, instead saying she felt ornamental, like a lamp: "It's pretty. Set it over there. Then when it's too bright, you throw it away."
This post has been updated.
so you want to be president


As part of The Feast Festival weekend we host a Ragroof Tea Dance alongside some extraordinary and captivating performances which will delight and surprise both young and old alike, together with free taster sessions and family activities.
Roll up for vintage tunes, dazzling dance displays, and whirlwind Instant Dance Classes to ease you onto the floor.
The Ragroof Players Tea Dance is a fantastic participatory event featuring DJs for discerning dancers playing authentic music from the 1920s to 1950s, vintage costumes, glorious dance displays, the company's trademark instant dance classes, and a chance for everyone to trip the light fantastic.
Everyone is welcome, no partners needed – and Ragroof's unique approach to partner dancing encourages everyone to learn the steps of both lead and follow, rather than be dictated to by gender.
So polish up your dancing shoes and join us – and if you fancy it, then do dress to impress, but it's not compulsory.


This is the new toy that will have some care and attention soon. It's a Yamaha Tz125 4JT 1994 model that I bought from a local racer a couple weeks back.
Even though it doesn't look that great, it's not in a bad shape at all and seems to be complete.
So, I suppose there will be a lot new posts with handmade parts, restoration photos etc.


text:
package org.apache.spark.launcher;

import java.io.File;
import java.util.ArrayList;
import java.util.List;
import java.util.Map;

/**
 * Helper methods for command builders.
 */
class CommandBuilderUtils {

  static final String DEFAULT_MEM = "1g";
  static final String DEFAULT_PROPERTIES_FILE = "spark-defaults.conf";
  static final String ENV_SPARK_HOME = "SPARK_HOME";
  static final String ENV_SPARK_ASSEMBLY = "_SPARK_ASSEMBLY";

  /** The set of known JVM vendors. */
  static enum JavaVendor {
    Oracle, IBM, OpenJDK, Unknown
  };

  /** Returns whether the given string is null or empty. */
  static boolean isEmpty(String s) {
    return s == null || s.isEmpty();
  }

  /** Joins a list of strings using the given separator. */
  static String join(String sep, String... elements) {
    StringBuilder sb = new StringBuilder();
    for (String e : elements) {
      if (e != null) {
        if (sb.length() > 0) {
          sb.append(sep);
        }
        sb.append(e);
      }
    }
    return sb.toString();
  }

  /** Joins a list of strings using the given separator. */
  static String join(String sep, Iterable<String> elements) {
    StringBuilder sb = new StringBuilder();
    for (String e : elements) {
      if (e != null) {
        if (sb.length() > 0) {
          sb.append(sep);
        }
        sb.append(e);
      }
    }
    return sb.toString();
  }

  /**
   * Returns the first non-empty value mapped to the given key in the given maps, or null otherwise.
   */
  static String firstNonEmptyValue(String key, Map<?, ?>... maps) {
    for (Map<?, ?> map : maps) {
      String value = (String) map.get(key);
      if (!isEmpty(value)) {
        return value;
      }
    }
    return null;
  }

  /** Returns the first non-empty, non-null string in the given list, or null otherwise. */
  static String firstNonEmpty(String... candidates) {
    for (String s : candidates) {
      if (!isEmpty(s)) {
        return s;
      }
    }
    return null;
  }

  /** Returns the name of the env variable that holds the native library path. */
  static String getLibPathEnvName() {
    if (isWindows()) {
      return "PATH";
    }

    String os = System.getProperty("os.name");
    if (os.startsWith("Mac OS X")) {
      return "DYLD_LIBRARY_PATH";
    } else {
      return "LD_LIBRARY_PATH";
    }
  }

  /** Returns whether the OS is Windows. */
  static boolean isWindows() {
    String os = System.getProperty("os.name");
    return os.startsWith("Windows");
  }

  /** Returns an enum value indicating whose JVM is being used. */
  static JavaVendor getJavaVendor() {
    String vendorString = System.getProperty("java.vendor");
    if (vendorString.contains("Oracle")) {
      return JavaVendor.Oracle;
    }
    if (vendorString.contains("IBM")) {
      return JavaVendor.IBM;
    }
    if (vendorString.contains("OpenJDK")) {
      return JavaVendor.OpenJDK;
    }
    return JavaVendor.Unknown;
  }

  /**
   * Updates the user environment, appending the given pathList to the existing value of the given
   * environment variable (or setting it if it hasn't yet been set).
   */
  static void mergeEnvPathList(Map<String, String> userEnv, String envKey, String pathList) {
    if (!isEmpty(pathList)) {
      String current = firstNonEmpty(userEnv.get(envKey), System.getenv(envKey));
      userEnv.put(envKey, join(File.pathSeparator, current, pathList));
    }
  }

  /**
   * Parse a string as if it were a list of arguments, following bash semantics.
   * For example:
   *
   * Input: "\"ab cd\" efgh 'i \" j'"
   * Output: [ "ab cd", "efgh", "i \" j" ]
   */
  static List<String> parseOptionString(String s) {
    List<String> opts = new ArrayList<String>();
    StringBuilder opt = new StringBuilder();
    boolean inOpt = false;
    boolean inSingleQuote = false;
    boolean inDoubleQuote = false;
    boolean escapeNext = false;

    // This is needed to detect when a quoted empty string is used as an argument ("" or '').
    boolean hasData = false;

    for (int i = 0; i < s.length(); i++) {
      int c = s.codePointAt(i);
      if (escapeNext) {
        opt.appendCodePoint(c);
        escapeNext = false;
      } else if (inOpt) {
        switch (c) {
        case '\\':
          if (inSingleQuote) {
            opt.appendCodePoint(c);
          } else {
            escapeNext = true;
          }
          break;
        case '\'':
          if (inDoubleQuote) {
            opt.appendCodePoint(c);
          } else {
            inSingleQuote = !inSingleQuote;
          }
          break;
        case '"':
          if (inSingleQuote) {
            opt.appendCodePoint(c);
          } else {
            inDoubleQuote = !inDoubleQuote;
          }
          break;
        default:
          if (!Character.isWhitespace(c) || inSingleQuote || inDoubleQuote) {
            opt.appendCodePoint(c);
          } else {
            opts.add(opt.toString());
            opt.setLength(0);
            inOpt = false;
            hasData = false;
          }
        }
      } else {
        switch (c) {
        case '\'':
          inSingleQuote = true;
          inOpt = true;
          hasData = true;
          break;
        case '"':
          inDoubleQuote = true;
          inOpt = true;
          hasData = true;
          break;
        case '\\':
          escapeNext = true;
          inOpt = true;
          hasData = true;
          break;
        default:
          if (!Character.isWhitespace(c)) {
            inOpt = true;
            hasData = true;
            opt.appendCodePoint(c);
          }
        }
      }
    }

    checkArgument(!inSingleQuote && !inDoubleQuote && !escapeNext, "Invalid option string: %s", s);
    if (hasData) {
      opts.add(opt.toString());
    }
    return opts;
  }

  /** Throws IllegalArgumentException if the given object is null. */
  static void checkNotNull(Object o, String arg) {
    if (o == null) {
      throw new IllegalArgumentException(String.format("'%s' must not be null.", arg));
    }
  }

  /** Throws IllegalArgumentException with the given message if the check is false. */
  static void checkArgument(boolean check, String msg, Object... args) {
    if (!check) {
      throw new IllegalArgumentException(String.format(msg, args));
    }
  }

  /** Throws IllegalStateException with the given message if the check is false. */
  static void checkState(boolean check, String msg, Object... args) {
    if (!check) {
      throw new IllegalStateException(String.format(msg, args));
    }
  }

  /**
   * Quote a command argument for a command to be run by a Windows batch script, if the argument
   * needs quoting. Arguments only seem to need quotes in batch scripts if they have certain
   * special characters, some of which need extra (and different) escaping.
   *
   *  For example:
   *    original single argument: ab="cde fgh"
   *    quoted: "ab^=""cde fgh"""
   */
  static String quoteForBatchScript(String arg) {

    boolean needsQuotes = false;
    for (int i = 0; i < arg.length(); i++) {
      int c = arg.codePointAt(i);
      if (Character.isWhitespace(c) || c == '"' || c == '=' || c == ',' || c == ';') {
        needsQuotes = true;
        break;
      }
    }
    if (!needsQuotes) {
      return arg;
    }
    StringBuilder quoted = new StringBuilder();
    quoted.append("\"");
    for (int i = 0; i < arg.length(); i++) {
      int cp = arg.codePointAt(i);
      switch (cp) {
      case '"':
        quoted.append('"');
        break;

      default:
        break;
      }
      quoted.appendCodePoint(cp);
    }
    if (arg.codePointAt(arg.length() - 1) == '\\') {
      quoted.append("\\");
    }
    quoted.append("\"");
    return quoted.toString();
  }

  /**
   * Quotes a string so that it can be used in a command string.
   * Basically, just add simple escapes. E.g.:
   *    original single argument : ab "cd" ef
   *    after: "ab \"cd\" ef"
   *
   * This can be parsed back into a single argument by python's "shlex.split()" function.
   */
  static String quoteForCommandString(String s) {
    StringBuilder quoted = new StringBuilder().append('"');
    for (int i = 0; i < s.length(); i++) {
      int cp = s.codePointAt(i);
      if (cp == '"' || cp == '\\') {
        quoted.appendCodePoint('\\');
      }
      quoted.appendCodePoint(cp);
    }
    return quoted.append('"').toString();
  }

}

redpajama_set_name: RedPajamaGithub


February 28, 2019 in Challenge: War of the Worlds, Ratings.
The season is off to a pretty good start, can it keep it up? Episode 3 was viewed by 834,000 people and received a rating of 0.52 in the 18-49 demographic. This is a bump upwards, the direction we want to go!
February 21, 2019 in Challenge: War of the Worlds, Ratings.
Second episode in, and we're getting Amanda drama. Are people tuning in? Episode 2 was viewed by 783,000 people and received a rating of 0.47 in the 18-49 demographic. A small dip, but still about on par with last season.
February 14, 2019 in Challenge: War of the Worlds, Ratings.
February 7, 2019 in Challenge: War of the Worlds, Ratings.
November 29, 2018 in Challenge: Final Reckoning, Ratings.
November 21, 2018 in Challenge: Final Reckoning, Ratings.


text:
Ethyl 9,9-dioctyl-4,7,11-trioxo-3,8,10-trioxa-9-stannatetradeca-5,12-dien-14-oate
Currently viewing: S-01 | Summary001 Key | Experimental result
EC50 > 1000 mg/L, NOEC = 1000 mg/L, OECD 209, Roulstone 2012
EC10 or NOEC for microorganisms:
1 000 mg/L
The effect of the test material on the respiration of activated sewage sludge was investigated in accordance with the standardised guideline OECD 209.
During the study activated sewage sludge was exposed to an aqueous dispersion of the test material at concentrations of 10, 100 and 1000 mg/L (3 replicates of the 1000 mg/L concentration) for a period of 3 hours at a temperature of 20 ± 2 °C with the addition of a synthetic sewage as a respiratory substrate. The rate of respiration was determined after 3 hours contact time and compared to data for the control and a reference item, 3,5-dichlorophenol.
Under the conditions of the test the 3 hour EC50 was determined to be in excess of 1000 mg/L and the NOEC was determined to be 1000 mg/L. It was considered unnecessary and unrealistic to test at concentrations in excess of 1000 mg/L. The reference item gave a 3 hour EC50 value of 11 mg/L (95 % confidence limits: 8.7 - 14 mg/L).
The study was performed in accordance with a standardised guideline and in line with GLP. The study was reported to a high standard, sufficient to assess the accuracy of the reported conclusions. The study was therefore assigned a reliability score of 1 in accordance with the criteria as defined by Klimisch (1997) and considered suitable for assessment as an accurate reflection of the test material.


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This season, jump in with the Phantom LX snorkeling combo. Confidently snorkel knowing you have superior comfort with top performance. The frameless mask delivers an adjustable, low-profile fit. Women will love the neoprene strap cover that keeps your mask in place without pulling on your hair.