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Samsung's response to a customer whose phone caught fire only made things worse
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Tech Help, Electronics, & Gaming Discuss Samsung's response to a customer whose phone caught fire only made things worse at the General Discussion; Damage control is a tricky thing: One wrong move can make a small crisis exponentially worse. Such is the case ...
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foundit66
Damage control is a tricky thing: One wrong move can make a small crisis exponentially worse. Such is the case for Samsung, which moved to suppress YouTube evidence that its Galaxy S4 smartphone can catch fire for no reason at all, only to have the original poster call the company out for it in a second video that received five times as many views as the first.
Samsung had itself to blame for the initial clip as well. In it, YouTuber ghostlyrich remarks that the company had demanded proof that his new phone was indeed defective before they would agree to replace it—they just didn't expect him to share that evidence with the world. We get a few closeups of the charred and melted charging port, along with an alarming hypothetical: The battery could have exploded, resulting in a much worse fire.
samsung galaxy s4 caught fire proof for samsung - YouTube
Ghostlyrich soon received a settlement proposal from Samsung that promised he could exchange his fried phone for "a similar model," but on several conditions. He would have to delete his YouTube video, promise not to upload similar material, officially absolve the company of all liability, waive his right to bring a lawsuit or other legal complaint, and never make the terms of this agreement public. A witness would also have to sign the form.
Sounds airtight, doesn't it? But Samsung didn't anticipate that ghostlyrich would twist the knife by conveying to his subscribers what steps the manufacturer was taking to brush a serious safety concern under the rug. Now almost half a million people have seen that Samsung won't provide the services outlined in their warranty until you sign some more rights away.
samsung galaxy s4 catches on fire samsung wants silence - YouTube
That should be a valuable lesson to businesses everywhere: You may be able to get away with selling a product that burns a few apartments down, but trying to censor whomever publicly complains about it will provide a crash course in the Streisand effect.
The Daily Dot - Samsung's response to a customer whose phone caught fire only made things worse
Glad this guy didn't blindly sign his rights away. The phone company should have just replaced it and worked to fix the issue.
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professional curmudgeon
Re: Samsung's response to a customer whose phone caught fire only made things worse
Samsung could have avoided this by just telling the customer how sorry they were and giving the guy a new phone. In today's world with the internet the people have a lot of power to turn the tables on a big company.
to the little guy
Sometimes by losing a battle you find a new way to win the war.
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What no free fire extinguisher with purchase of every phone?
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waltky
Location: Okolona
Will they be half-priced?...
Samsung Plans to Sell Refurbished Galaxy Note 7s
March 28, 2017 — Tech giant Samsung Electronics plans to sell refurbished versions of the Galaxy Note 7 smartphones, the company said late on Monday, signaling the return of the model pulled from markets last year because of fire-prone batteries.
Samsung's Note 7s were permanently scrapped in October after some phones self-combusted, prompting a global recall roughly two months after the launch of the near-$900 devices. A subsequent investigation found manufacturing problems in batteries supplied by two companies — Samsung SDI Co and Amperex Technology. Analysis from Samsung and independent researchers found no other problems in the Note 7 devices except the batteries, raising speculation that Samsung will recoup some of its losses by selling refurbished Note 7s. A person familiar with the matter told Reuters in January that it was considering the possibility of selling refurbished versions of the device or reusing some parts.
Samsung's announcement that revamped Note 7s will go back on sale, however, surprised some with the timing - only days before it launches its new S8 smartphone on Wednesday in the United States, its first new premium phone since the debacle last year. Under pressure to turn its image around after the burning battery scandal, Samsung had previously not commented on its plans for recovered phones. "Regarding the Galaxy Note 7 devices as refurbished phones or rental phones, applicability is dependent upon consultations with regulatory authorities and carriers as well as due consideration of local demand," Samsung said in a statement.
A customer holds a Samsung Electronics Galaxy Note 7 smartphone at the headquarters of South Korean mobile carrier KT in Seoul, South Korea
South Korea's Electronic Times newspaper, citing unnamed sources, said on Tuesday that Samsung will start selling refurbished Note 7s in its home country in July or August and will aim to sell between 400,000 and 500,000 of the Note 7s using safe batteries. Samsung said in a statement to Reuters that the company has not set specifics on refurbished Note 7 sales plans, including what markets and when they would go on sale, though it also said it does not plan to sell refurbished Note 7s in India or the United States. The company said refurbished Note 7s will be equipped with new batteries that have gone through Samsung's new battery safety measures. "The objective of introducing refurbished devices is solely to reduce and minimize any environmental impact," it said.
The company estimated that it took a profit hit of $5.5 billion over three quarters because of the Note 7's troubles. It had sold more than 3 million of the phones before taking the model off the market. Samsung also plans to recover and use or sell reusable components such as chips and camera modules, as well as rare metals such as copper, gold, nickel and silver from Note 7 devices it opts not to sell as refurbished products. Environment rights group Greenpeace and others had urged Samsung to come up with environmentally friendly ways to deal with the recovered Note 7s. Greenpeace said in a separate statement on Monday that it welcomed Samsung's decision and that the company should carry out its plans in a verifiable manner.
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Originally Posted by waltky
wow way to thin the population, South K.
"In the depth of winter, I finally learned that there was in me an invincible summer."
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Samsung bringin' back Refurbished Note 7 Smartphone...
Samsung to Sell Refurbished Note 7 Smartphone
July 02, 2017 - Samsung Electronics said Sunday it will start selling refurbished versions of the Galaxy Note 7 smartphone this week in South Korea.
The Note 7 was recalled last year because its batteries would overheat and catch fire. The refurbished versions will use different batteries. The new Galaxy Note FE phone, built with unused components of the Note 7, will cost $611, a significant drop in price from the Note 7's price tag of nearly $1,000. Samsung recalled the Note 7 less than a month after its launch when reports of the phone's batteries catching fire emerged.
The company released another Note 7 with replaced batteries, but those batteries also overheated and Samsung discontinued the Note 7. Earlier this year, the tech giant released the results of an investigation that determined the phone fires were the result of flaws in the design and production of batteries supplied by two battery makers.
Close to 3 million Note 7s were returned to Samsung, prompting environmental groups to urge the South Korean company to reuse the electronics parts of the Note 7 to reduce waste. "The latest launch of the Galaxy Note FE ... has a significant meaning as an environment-friendly project that minimized the waste of resources," Samsung said in a statement. Samsung said it has not decided if it will sell the Note FE internationally.
https://www.voanews.com/a/samsung-to...e/3924910.html
Samsung Recycles, Sells Galaxy Note 7 in South Korea
July 02, 2017 — Samsung Electronics said Sunday its recalled Galaxy Note 7 phones will be recycled and sold starting this week in South Korea.
The Galaxy Note FE phone, using unused parts in the recalled Note 7 smartphones, will go on sale in South Korea Friday at 700,000 won ($611), about three quarters of its original price. The company said the supply will be limited to 400,000 units. Overseas sales plans will be determined later, it said in a statement.Samsung said the Note FE has "perfect safety."
Black eye for Samsung
The original Note 7 was one of the biggest black eyes in Samsung's history. When it was launched in August 2016, the Note 7 was Samsung's answer to Apple's upcoming iPhone. It was also one of the most expensive Samsung phones with the price starting at $850. But after reports emerged that its batteries were prone to overheat and catch fire, Samsung recalled the phone in less than a month of its launch and released another one with replaced batteries. But the second batch also tended to overheat, prompting Samsung to discontinue the Note 7.
The burned Samsung Note 7 smartphone belonging to Brian Green is pictured in this undated handout photo obtained by Reuters, Oct. 6, 2016.
The debacle dealt a blow to Samsung's corporate image. Aviation authorities around the world banned the pricy phone on flights and photos of scorched Note 7s circulated on social media. Samsung spent billions of dollars to recall the Note 7 and fix its damaged brand. Earlier this year, the company released the investigation results and blamed flaws in design and production of batteries supplied by two battery makers.
Environmentalists urged reuse of parts
After Samsung recalled millions of Note 7 phones, environmental activists have pressured the South Korean tech giant to reuse the electronics parts to reduce waste. Samsung said the Note FE is part of its efforts to minimize waste. The Note FE, short for "Fan Edition," features the screen measuring 5.7 inches (14.48 centimeters) diagonally and the stylus pen.
https://www.voanews.com/a/samsung-re...a/3924871.html
caught, customer, fire, made, only, phone, response, samsung, things, whose, worse
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Stronghold EUR: lower risk in September and negative yield advantage
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Summary: Stronghold EUR delivered 0.2% return in September compared to 0.7% for the benchmark as higher rates negatively impacted the portfolio. During September and early October the model has reduced exposure in momentum equities as the volatility structure in this asset class has changed for the worse as a result of the mini-crash in US momentum equities during September. The model has added the global properties asset class for the first time since inception.
September was a more difficult month for the Stronghold EUR delivering only 0.2% compared to 0.7% for the benchmark portfolio as rates climbed on the backdrop of higher risk sentiment by global investors. The Stronghold EUR portfolio is up 12.1% as of September compared to the benchmark up 3.5% in the same period. The model's significant exposure to minimum volatility equities and long duration bonds have contributed to performance on a relative and absolute basis. The annualized Sharpe ratio is currently 0.9 and this year's performance relative to the benign drawdown in Q4 2018 is among the better when we compare the model against its peers. Clients have noticed this leading to material client net inflow into the strategy in Q3 2019.
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Midfielder backs himself with set-pieces after third successful free-kick of Latics career.
"Beckham? Beckham who?" – Pennant jokes after Fulham strike.
Former Liverpool and Arsenal man pleased with style of play under Gary Caldwell.
32-year-old disappointed not to take all three points from Craven Cottage.
Latics midfielder Jermaine Pennant was disappointed not to come away from the capital with all three points on Friday evening as Gary Caldwell's first match in charge ended in a 2-2 draw.
Ross McCormack and Matt Smith twice gave the hosts the lead after Pennant equalised and before Jason Pearce levelled the score in the second-half.
Reflecting on the game with Latics Player, Pennant praised the character of the players and the style under new boss Caldwell.
"They had two strikes in the first-half, good strikes, and we found ourselves 2-1 down but all credit to the lads, we didn't drop our heads, we kept battling on and got the second," Pennant explained.
"Full credit to the lads, it was a fantastic performance and we're a little disappointed we didn't come away with three points.
"I enjoyed getting the ball down and passing it, it got me more involved, it got the players up front involved as well too and it shows just how good we are technically – we could have played like this ten games ago and who knows what could have happened – but each manager has got their own style.
Pennant's third goal of his brief Latics career to date was another free-kick whilst he also provided the set-piece that Pearce levelled from.
And the midfielder says he is feeling confident from dead ball situations.
"Just place the ball down there [25 yards from goal left of centre] and I'll put it in the back of the net!
"Beckham? Beckham who? He joked.
"I practice free-kicks all the time in training, I've been known for my set-pieces and my ability to cross the ball from an early age and now I have come of age and finally mastered it.
"Every time I'm stepping up to the ball, I'm feeling confident.
Pennant sprinted a good 70-80 yards to celebrate his strike with the travelling Wigan Athletic support and he added that it was a nice moment for him.
"It's nice to give something to the fans to share the emotion of scoring the goal; I got a bit of stick last time for going to the manager and the lads on the bench so I thought I'd go straight to the fans.


Facebook's Business Accounts are specialised for managing Facebook Pages and also Facebook Ads. How To Get A Business Facebook Account - You could think about them as stripped down Individual Profiles that don't have a public presence. A Facebook Business Account should be attached to a Facebook Page to begin with. If your not-for-profit currently has a Facebook Page, you can Create a 'dummy' Page to Create the Business Account, after that include the Business Account as an admin to your Facebook Page and also remove the 'dummy' Page.
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Madras HC lifts ban on online sale of medicines. Paving the way for resumption online medicine sale, Madras high court has stayed a single judge order prohibiting online business of medicines.
The bench then posted the appeal for final hearing on January 24. The Tamil Nadu Chemists and Druggists Association had filed a case against the sale of drugs by online companies.
"We are extremely grateful for the observations made by bench which validates the work that we have put in for the last three years," said Dadha.
On a plea filed by the Tamil Nadu Chemists and Druggists Association, Judge Pushpa Sathyanarayana on December 17 directed the Centre to notify the rules governing the online sale of medicines on or before January 31 and stayed the operation of e-pharmacies till then.
The judge kept the implementation of her order in abeyance following a host of senior counsel representing the e-pharma companies. Online pharmacy firms including 1MG Technologies, Netmeds Market Place, 91 Streets Media Technologies, Medlife International and Practo Technologies were impleaded in the case.


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Matilde Gouveia é a personagem protagonista da terceira série da telenovela juvenil da TVI, Morangos com Açúcar, interpretada por Joana Duarte. Matilde é uma rapariga muito responsável que cuida dos irmãos mais novos Manel (Tiago Felizardo) e Bia (Mariana Monteiro), no lugar dos seus pais ausentes Luis (Rui Madeira) e Helena (Isabel Medina).
Antes de ingressar no Colégio da Barra para o seu 12º ano, Matilde faz uma viagem a Cuba no Verão, com a sua amiga Vera (Paula Neves) e conhece Tiago (Luis Lourenço), um rapaz a quem salva a vida num acidente de mergulho. Convencidos que são estrangeiros e que nunca mais se voltarão a ver, os dois jovens voltam para Cascais no mesmo avião sem nunca se encontrarem. Mais tarde, Bia encontra Tiago e os dois acabam por se tornar namorados. Matilde marca uma festa de aniversário para a irmã no Oceanário de Lisboa e convida Tiago sem saber quem ele é. Quando se reencontram, os jovens decidem recuperar o tempo perdido, pelo que Matilde falta à festa da irmã. Bia descobre e tenta vingar-se da irmã, até que um amigo, Cristiano (Miguel Bogalho) se apaixona por ela e a ajuda a esquecer Tiago.

Devido a uma discussão entre Tiago e Manel que acaba em violência, Matilde acaba o namoro com ele. Tiago começa então a namorar com uma colega da Escola Secundária dos Navegantes e de voluntariado no hospital, Cláudia. Matilde, por sua vez, inicia uma relação com o melhor amigo de Tiago, Afonso (Francisco Côrte-Real). No final da terceira série, os dois percebem finalmente que ainda gostam um do outro e acabam juntos após uma série de peripécias.

No Colégio da Barra, o grupo de amigas de Matilde inclui Marta (Ana Guiomar), Maria (Dânia Neto), Salomé (Ciomara Morais) e Susana (Diana Chaves). Na sua turma estão ainda Topê (Paulo Vintém), Crómio (Tiago Castro) e Tojó (Diogo Valsassina), bem como a "Popstar" Mónica (Helena Costa) e Nelson (João Pedro Sousa), seu ex-namorado que a tentou violar. Nos tempos livres, Matilde dança Hip Hop nas aulas de Zé Milho (Vítor Fonseca), pratica mergulho, ou encontra-se com os amigos no Bar do Fred.

No verão o seu grupo de amigas é constituido pela sua irmã Bia, Susana, Becas (Sara Prata), Mimi (Jessica Athaide), Catarina (Filipa Oliveira) e as gémeas Rita (Margarida Martinho) e Silvia (Mariana Martinho). Passa grande parte do seu tempo da Surf House de Diana (Sofia Cró).

Ver também
 Blog da personagem Matilde Gouveia

Personagens de séries de televisão
Morangos com Açúcar

redpajama_set_name: RedPajamaWikipedia


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Ms. Melody Smith
Ms. Melody Smith is a retired Army Lieutenant Colonel and Lean Six Sigma Green Belt currently serving as the Associate Dean of Administration and Chief of Staff for the Center for the Study of Weapons of Mass Destruction.
From 2013-2015, Ms. Smith served as the Deputy Chief of Staff for the Center for the Study of Weapons of Mass Destruction where she coordinated the organization and execution of Center educational activities and outreach efforts.
From 2006-2009, LTC Smith was a Joint Staff Action Officer in the Logistics Directorate, Strategy Division where she developed, reviewed and assessed military logistics strategy and doctrine to ensure synchronization with national military objectives and US policy. During this time, LTC Smith led the development and publication of the first major rewrite of Joint Publication 4-0, Joint Logistics – the senior hierarchal logistics doctrine which provides strategic guidance for all U.S. military logistics operations.
From 2003-2006, LTC Smith was the Deputy Commander and Deputy District Engineer of the Rock Island Engineer District where she managed a $130 million, civil works operating budget in a 1000-person public engineering organization. She was directly responsible for the supervision and training of 10 senior staff chiefs in an organization that provided navigation flood control, water resources planning, ecosystem restoration and regulatory functions in a five-state area encompassing over 78,000 square miles. In 2005, LTC Smith served a tour in Iraq as the Resident Engineer Officer in Charge, Al Anbar Province. She provided support to the II Marine Expeditionary Force and Multinational Forces, Iraq and led a team of 11 senior project engineers and managed over 52 construction projects valued at over $85 million.
From 2001-2003, MAJ Smith was a Construction Program Manager for the Defense Threat Reduction Agency where she led a $3 million project to renovate facilities and relocate a 500-person organization. She also provided oversight to personnel, budget, security, and administrative actions within the Acquisition and Logistics Directorate.
From 1998-2001, MAJ Smith was the Operations Officer for the US Army Japan Command Operations Center. She led a multifunctional staff of 11 personnel for the daily operations of the headquarters. During this assignment, she was deployed to Sarajevo, Bosnia where she provided engineer support to 531 U.S. personnel supporting NATO's peace enforcement mission and managed a $4 million operating budget during OPERATION JOINT FORGE.
From 1989-1998, CPT Smith served in a multitude of assignments as platoon leader, executive officer, adjutant, and company commander. She also deployed to Saudi Arabia in support of OPERATION DESERT SHIELD.
Ms. Smith is a graduate of the United States Military Academy and holds a B.S. in Engineering. Her military decorations include the Legion of Merit, Bronze Star Medal, Defense Meritorious Service Medal, Meritorious Service Medal (3), Joint Service Commendation Medal (2), Army Commendation Medal (3), Army Achievement Medal, National Defense Service Medal (2), the Global War on Terrorism Expeditionary Medal, Global War on Terrorism Service Medal, Armed Forces Expeditionary Medal, Army Service Ribbon, Overseas Service Ribbon, NATO Medal, Kuwaiti Liberation Medal, and the Joint Chiefs of Staff Identification Badge.


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News > Medscape Medical News
FDA Panel Rejects Empagliflozin for Use in Type 1 Diabetes
Alicia Ault
SILVER SPRING, Maryland — A US Food and Drug Administration (FDA) advisory committee has recommended against approval of empagliflozin (Boehringer Ingelheim, Jardiance), a sodium-glucose cotransporter type 2 (SGLT2) inhibitor, as an adjunct to insulin therapy to improve glycemic control in adults with type 1 diabetes mellitus.
If the FDA follows the committee's advice, it would be the third drug in the class to be rejected for the treatment of type 1 diabetes.
The FDA turned down approval of another SGLT2 inhibitor, dapagliflozin (Forxiga, AstraZeneca), in July, as well as the dual SGLT1/SGLT2 inhibitor sotagliflozin (Zynquista, Sanofi/Lexicon) in March, as reported by Medscape Medical News.
The European Union, however, has approved both dapagliflozin and sotagliflozin as an adjunct to insulin for the treatment of type 1 diabetes.
Physician Panelists Cite Insufficient Data
The FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 14 to 2 that empagliflozin should not be approved for type 1 diabetes. The drug has been on the market for type 2 diabetes since 2014.
Most of the panelists said there were too few data to evaluate either the efficacy or the safety of empagliflozin — especially given that the SGLT2 inhibitor class is associated with an elevated risk for diabetic ketoacidosis (DKA) in the setting of type 1 diabetes.
The panel said that Boehringer needed to conduct longer-term studies with a much larger group of patients. The company submitted data from a single phase 3 trial — the Empagliflozin as Adjunctive to Insulin Therapy (EASE-3) — which included just 241 patients taking empagliflozin. Primary endpoints were collected at 26 weeks.
"I think we have insufficient data on the benefits and the risks of this drug," said panelist Jack A. Yanovski, MD, PhD, a pediatric endocrinologist at the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.
James De Lemos, MD, agreed: "I'm just completely unconvinced by the data provided because it's too small and too short an exposure period."
De Lemos, a professor of medicine and chair in cardiology at UT Southwestern Medical Center, Dallas, Texas, said he believes empagliflozin holds promise in this indication, but for now, "Giving a drug that can cause DKA to patients with type 1 diabetes makes me nervous intrinsically."
Brendan Everett, MD, MPH, FACC, FAHA, said he too thought empagliflozin could be an effective therapy.
But he said, "We owe this to patients with type 1 diabetes to do this right."
A 241-patient study "doesn't quite meet that bar in terms of respecting the breadth and severity of illness in the patient population that we're hoping to address with this therapy," said Everett, director of general cardiology inpatient service at Brigham and Women's Hospital, Boston, Massachusetts.
"It's out of respect for them that I voted no," he emphasized.
But Some Patients Call for Approval
But one of the patient advocates on the panel voted to recommend approval of empagliflozin, and some advocates who spoke at the public hearing also urged the panel to give the drug the thumbs up, noting that SGLT2 inhibitors are being used off label in type 1 diabetes anyway.
Bruce A. Perkins, MD, MPH, who helped coordinate the empagliflozin trials for Boehringer and who himself has type 1 diabetes, said that despite technologic advances, glucose is still not adequately controlled for people with type 1 diabetes.
"We need to acknowledge there's an epidemic of high A1C in the type 1 population." The ability of empagliflozin to reduce A1C "compares similarly to some of the incredibly complex interventions that we apply in type 1 diabetes," said Perkins, professor of medicine in the Division of Endocrinology and Metabolism, University of Toronto, Ontario, Canada.
And given the ongoing off-label use, the drug should be approved, said Anna McCollister-Slipp.
"Do we want people to take this class of medications without knowing what's happening?" she asked fellow panelists. "I would rather have that happen in a regulated environment" where manufacturers have greater responsibility to collect data, she stressed.
Kelly Close, cofounder of the nonprofit diaTribe Foundation, also argued during the public hearing that a "more conservative approval" could help physicians decide which patients with type 1 diabetes would be good candidates for an SGLT2 inhibitor.
It also would give physicians and patients more concrete guidance on side effects, Close said.
A diaTribe survey of some 90 patients with type 1 diabetes who were taking the drugs off label found that most were doing it to lower their A1C level, to have fewer instances of hyperglycemia, and to spend more time in their target range, she noted.
And McCollister-Slipp, who is also a type 1 diabetes patient, stressed that patients "live with risk" every day. "You hear all the time about patients dying not because of this study drug, or other study drugs, but because of the inadequacy of treatments," she stressed.
Fellow panelist and advocate Carling Lellock, who also has type 1, said she was concerned about a heightened possibility of DKA with empagliflozin, but she noted, "It's a risk we're already taking."
Even so, she voted against approval because she wanted to see more data.
One physician panel member who voted to approve the drug said that though it would be nice to see more data, he did not expect different outcomes.
Given what's already known about the class, "the data were what I'd expected them to be," said Kashif Munir, MD, vice chief of diabetes and nutrition in the Division of Endocrinology, Diabetes and Nutrition at the University of Maryland School of Medicine, Baltimore.
"I didn't feel like this trial was a surprise or anything unexpected or anything I wouldn't have predicted," he said.
DKA Risk Not Fully Characterized, Some Cases Overlooked
In EASE-3, Boehringer came up with a handful of classifications of DKA and DKA-related events that were referred to a blinded safety committee for adjudication. The FDA reviewers were critical, however, of that classification system.
The company said that 2 of 241 patients taking the pivotal 2.5-mg dose of empagliflozin experienced "certain DKA," compared to three patients taking placebo. Four patients in each arm had "certain or potential DKA," while seven patients taking empagliflozin (and two taking placebo) had "unlikely DKA but ketosis" and zero patients (one taking placebo) had "unlikely DKA."
But FDA reviewer Mahtab Niyyati, MD, said the agency had concerns about the reliability of the adjudication and disagreed with what seemed to be a glossing over of the seriousness of some of the events by virtue of how they were classified.
Some cases that were classified as "unlikely DKA but ketosis" were clinically significant, serious events that necessitated hospitalization and prompt intervention, said Niyyati.
She also said the "unlikely" and the "potential" categories were "an artificial categorization of DKA risk."
Key is the fact that the FDA and panelists both were concerned that some cases may have been overlooked.
"I personally think some of the cases were missed or not appropriately categorized," said panel chairman Kenneth Burman, MD, chief of the Endocrine Section at Medstar Washington Hospital Center, Washington, DC.
He and other panel members also said that once the drug was widely available, DKA incidents could greatly increase.
Head of drug safety, metabolism, at Boehringer Ingelheim, Ona Kinduryte Schorling, MD, said: "We understand that the risk of DKA might be higher in a postmarketing setting."
As such, the company proposed a risk mitigation strategy with a host of measures designed to ensure that prescribers and patients are made aware of the risks, the signs and symptoms, and what to do in an emergency.
But many on the panel said the company had not submitted any evidence that such a strategy would work.
Effectiveness of 2.5-mg Dose of Empagliflozin Debated
Empagliflozin was initially approved in 2014 at doses of 10 mg and 25 mg as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. For type 1 diabetes, Boehringer studied 2.5-mg, 10-mg, and 25-mg doses.
EASE-2, a double-blind, randomized, controlled phase 3 study, only investigated the 10- and 25-mg doses, which the company realized presented too high a risk for DKA. EASE-3 was the only pivotal study that included the 2.5-mg dose. The company also submitted a simulation model that was meant to serve as a substitute for a second phase 3 trial.
Results from the whole EASE program were first presented at the EASD meeting in 2018, as reported by Medscape Medical News.
Both Boehringer and the FDA reviewers agreed that at 26 weeks, the 2.5-mg dose achieved a significant reduction of A1C from baseline of 0.26%. But the FDA noted that the figure was a result of a 0.20% increase in the placebo group and a 0.5% reduction in the empagliflozin group.
Most panelists said they could not draw conclusions on whether the A1C reduction was significant or meaningful.
"I feel that this database on the dose of 2.5 mg is too small and too short of a time period to even know what the efficacy in terms of glycemic control may be," said Connie Newman, MD.
"The purported reduction of 0.26% may not actually be clinically meaningful," said panelist Newman, adjunct professor of medicine at NYU Langone School of Medicine, New York City.
De Lemos agreed: "The clinical meaningfulness of this small reduction is completely unclear."
He and Newman, along with others on the panel, also raised questions about how long the reduction might last.
And the FDA said that secondary measures, such as a 1.77-kg reduction in body weight when compared with placebo and a 2-mmHg drop in systolic blood pressure compared to placebo were too small to be significant, especially in patients whose measures at baseline were normal for both.
The data also showed no difference from placebo regarding hypoglycemia risk; there was no excess hypoglycemia, but also no reduction compared to placebo, said the agency.
Newman, among others on the panel, agreed that the need for additional safe and effective treatments for type 1 patients is great. She and others called for longer studies to verify the duration of treatment effect and to better characterize the safety of empagliflozin.
"There should be at least one additional clinical randomized controlled trial of at least 1 year duration with a consideration to including microvascular outcomes," said Newman, who added that any such research should perhaps be extended another year through an open-label study.
For more diabetes and endocrinology news, follow us on Twitter and Facebook
Medscape Medical News © 2019
Cite this: FDA Panel Rejects Empagliflozin for Use in Type 1 Diabetes - Medscape - Nov 14, 2019.
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Australia's in the middle of a campaign right now to cut out single-use plastic bags, straws, bottles, etc. And it's making me think about human behaviour.
How often do you ignore something wrong, something as simple as a discarded can lying in the gutter? Simply because you didn't drop it there, or you didn't have time to pick it up and find a rubbish bin, or you didn't want to get your hands dirty. Fair enough.
It happens. We all feel that way at times.
Do you see what I mean? If we all decide personally to do something positive, every day, it could create a massive impact. Start simple, work your way up. Pick up that rubbish; don't buy the takeaway food in all its throwaway packaging; help your neighbours move something; tell the people down the street that their poor dog barks for hours on end when they're out; call the police if you hear a disturbance next door; ask authorities to investigate if you think something terribly wrong is happening to that child.
Well, it may not be MY fault, but I can be part of the change, by doing something good every day.
YOU can be part of the change, by doing something good every day.
WE can be part of the change, by doing something good every day.
This entry was posted in Environment, Personal and tagged behaviour, Doing the right thing, Environmental concerns, positivity, why not. Bookmark the permalink.
Perfect post Carolyn and oh so true. I think too if our children/ grandchildren see us doing these things they will grow up and see this as the norm. I'm loving the idea of plastic bag free shopping ( I have been taking my own bags for years).


text:
Swansea sign defender Harries from Coventry
Mausam
LONDON: Swansea City have signed 20-year-old defender Cian Harries from Coventry City on a three-year deal subject to international clearance, the Premier League club said on Monday.
The under-20 Wales international is a product of Coventry's youth academy and played 16 games for the senior side last season as the club were relegated to League Two, the fourth tier of English football.
"I am delighted to be here," Harries told Swansea's website.
"My aim in the long term is to play in the Premier League. If I am lucky enough and good enough for the manager to trust me at some stage in the future, that would be a dream come true.
"But I am going into the development squad and that's good. I feel it will give me a chance to work on the areas where I need to improve."
Harries also played in the League Trophy final at Wembley last season as Coventry beat Oxford United.
#English Premier League #England #Swansea City #Coventry City #Cian Harries
Wade dumped from Australia's test squad for South Africa tour


text:
Home News Arty Members Club NeueHouse Adds a Location in Venice Beach, California—Complete With...
Arty Members Club NeueHouse Adds a Location in Venice Beach, California—Complete With Surfboard Storage
With its elegant, art-focused hospitality, NeueHouse has just opened its third West Coast location in Venice Beach, California, nipping at the heels of Soho House. Like its competitor, NeueHouse has erected private club/coworking outposts in downtown Los Angeles and, just eight miles to the west, Hollywood.
But the seaside NeueHouse, opened recently, could give Soho House's Little Beach House in Malibu a run for its money and glitterati clientele. In addition to the expected coworking spaces, meeting rooms, and house-roasted coffee, it boasts a podcast recording studio and beachy must-haves of post-ocean swim showers and surfboard storage.
Venice NeueHouse members include filmmaker Lucy Walker, fashion designer-turned-artist Rogan Gregory, costume designer/event impresario Lysa Cooper, and Squarespace Chief Creative Officer David Lee. Barry Diller, Diane Von Fursternburg, and Goodwin Gao, who owns the iconic Bradbury Building, where NeueHouse houses its downtown location, are reported to be investors.
"Members have been settling in, bringing new creative energy to an address with an inspired cultural legacy," said a December 16 post on the NeueHouse Instagram account.
Brick exterior of Venice NeueHouse. Courtesy of NeueHouse.
A block from the sandy berm known for its two-mile boardwalk of bohemian performers and mystics, and the birth of skateboarding, NeueHouse occupies the brick, two-story corner building at 73 Market Street. Built in 1922, it was most recently owned by the social media platform Snap.
An interior overhaul by Toronto-based DesignAgency has captured Venice's dual design motifs of nature (think wood paneling, greenery, and airy spaces) and mid-century modernism (the town brims with postwar bungalows). NeueHouse intends for the experience of the space, its hospitality, art shows, and collaborative projects to be "an accelerator for creative potential, cultural progress, and new ideas."
There's quite a lot of Hollywood cred to the building, which buzzed from 1977-2014 with film production companies when Oscar-winning director and producer Tony Bill () was landlord. Techies will likely be among those flocking to NeueHouse's open or private workspaces and soon-to-open rooftop restaurant (called Reunion), since the three-square-mile town of Venice, dubbed "Silicon Beach," is the third-largest tech hub in the U.S., after Seattle and San Francisco.
Catering to the global art scene, NeueHouse also runs a Manhattan location and will soon open a spot in Miami. In addition to its slate of cultural programming, it has established a partnership with Frieze for combined access to the art fair's events and membership-only perks. Memberships range from access to coworking areas at $595 a month to "Salon" membership starting at $4,200 a year.
"I love seeing people inspired in a setting," Josh Wyatt, CEO of CultureWorks, which owns NeueHouse, told Penta magazine earlier this year. "You can do that through curation, design and architecture and teams. All those wrapped together is what I've been doing."
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text:
package org.foo.paint;

import java.awt.*;
import java.awt.event.*;
import java.util.HashMap;
import java.util.Map;
import javax.swing.*;
import org.foo.shape.SimpleShape;
import org.foo.shape.circle.Circle;
import org.foo.shape.square.Square;
import org.foo.shape.triangle.Triangle;

/**
 * This class represents the main application class, which is a JFrame subclass
 * that manages a toolbar of shapes and a drawing canvas. This class does not
 * directly interact with the underlying OSGi framework; instead, it is injected
 * with the available <tt>SimpleShape</tt> instances to eliminate any
 * dependencies on the OSGi application programming interfaces.
 **/
public class PaintFrame extends JFrame implements MouseListener, MouseMotionListener {
  private static final long serialVersionUID = 1L;
  private static final int BOX = 54;
  private JToolBar m_toolbar;
  private String m_selected;
  private JPanel m_panel;
  private ShapeComponent m_selectedComponent;
  private Map m_shapes = new HashMap();
  private ActionListener m_reusableActionListener = new ShapeActionListener();

  /**
   * Default constructor that populates the main window.
   **/
  public PaintFrame() {
    super("PaintFrame");

    m_toolbar = new JToolBar("Toolbar");
    m_panel = new JPanel();
    m_panel.setBackground(Color.WHITE);
    m_panel.setLayout(null);
    m_panel.setMinimumSize(new Dimension(400, 400));
    m_panel.addMouseListener(this);
    getContentPane().setLayout(new BorderLayout());
    getContentPane().add(m_toolbar, BorderLayout.NORTH);
    getContentPane().add(m_panel, BorderLayout.CENTER);
    setSize(400, 400);
  }

  /**
   * This method sets the currently selected shape to be used for drawing on the
   * canvas.
   *
   * @param name The name of the shape to use for drawing on the canvas.
   **/
  public void selectShape(String name) {
    m_selected = name;
  }

  /**
   * Retrieves the available <tt>SimpleShape</tt> associated with the given
   * name.
   *
   * @param name The name of the <tt>SimpleShape</tt> to retrieve.
   * @return The corresponding <tt>SimpleShape</tt> instance if available or
   *         <tt>null</tt>.
   **/
  public SimpleShape getShape(String name) {
    return (SimpleShape) m_shapes.get(name);
  }

  /**
   * Injects an available <tt>SimpleShape</tt> into the drawing frame.
   *
   * @param name The name of the injected <tt>SimpleShape</tt>.
   * @param icon The icon associated with the injected <tt>SimpleShape</tt>.
   * @param shape The injected <tt>SimpleShape</tt> instance.
   **/
  public void addShape(SimpleShape shape) {
    m_shapes.put(shape.getName(), shape);
    JButton button = new JButton(shape.getIcon());
    button.setActionCommand(shape.getName());
    button.setToolTipText(shape.getName());
    button.addActionListener(m_reusableActionListener);

    if (m_selected == null) {
      button.doClick();
    }

    m_toolbar.add(button);
    m_toolbar.validate();
    repaint();
  }

  /**
   * Removes a no longer available <tt>SimpleShape</tt> from the drawing frame.
   *
   * @param name The name of the <tt>SimpleShape</tt> to remove.
   **/
  public void removeShape(String name) {
    m_shapes.remove(name);

    if ((m_selected != null) && m_selected.equals(name)) {
      m_selected = null;
    }

    for (int i = 0; i < m_toolbar.getComponentCount(); i++) {
      JButton sb = (JButton) m_toolbar.getComponent(i);
      if (sb.getActionCommand().equals(name)) {
        m_toolbar.remove(i);
        m_toolbar.invalidate();
        validate();
        repaint();
        break;
      }
    }

    if ((m_selected == null) && (m_toolbar.getComponentCount() > 0)) {
      ((JButton) m_toolbar.getComponent(0)).doClick();
    }
  }

  /**
   * Implements method for the <tt>MouseListener</tt> interface to draw the
   * selected shape into the drawing canvas.
   *
   * @param evt The associated mouse event.
   **/
  public void mouseClicked(MouseEvent evt) {
    if (m_selected == null) {
      return;
    }

    if (m_panel.contains(evt.getX(), evt.getY())) {
      ShapeComponent sc = new ShapeComponent(this, m_selected);
      sc.setBounds(evt.getX() - BOX / 2, evt.getY() - BOX / 2, BOX, BOX);
      m_panel.add(sc, 0);
      m_panel.validate();
      m_panel.repaint(sc.getBounds());
    }
  }

  /**
   * Implements an empty method for the <tt>MouseListener</tt> interface.
   *
   * @param evt The associated mouse event.
   **/
  public void mouseEntered(MouseEvent evt) {}

  /**
   * Implements an empty method for the <tt>MouseListener</tt> interface.
   *
   * @param evt The associated mouse event.
   **/
  public void mouseExited(MouseEvent evt) {}

  /**
   * Implements method for the <tt>MouseListener</tt> interface to initiate
   * shape dragging.
   *
   * @param evt The associated mouse event.
   **/
  public void mousePressed(MouseEvent evt) {
    Component c = m_panel.getComponentAt(evt.getPoint());
    if (c instanceof ShapeComponent) {
      m_selectedComponent = (ShapeComponent) c;
      m_panel.setCursor(Cursor.getPredefinedCursor(Cursor.MOVE_CURSOR));
      m_panel.addMouseMotionListener(this);
      m_selectedComponent.repaint();
    }
  }

  /**
   * Implements method for the <tt>MouseListener</tt> interface to complete
   * shape dragging.
   *
   * @param evt The associated mouse event.
   **/
  public void mouseReleased(MouseEvent evt) {
    if (m_selectedComponent != null) {
      m_panel.removeMouseMotionListener(this);
      m_panel.setCursor(Cursor.getPredefinedCursor(Cursor.DEFAULT_CURSOR));
      m_selectedComponent.setBounds(evt.getX() - BOX / 2, evt.getY() - BOX / 2, BOX, BOX);
      m_selectedComponent.repaint();
      m_selectedComponent = null;
    }
  }

  /**
   * Implements method for the <tt>MouseMotionListener</tt> interface to move a
   * dragged shape.
   *
   * @param evt The associated mouse event.
   **/
  public void mouseDragged(MouseEvent evt) {
    m_selectedComponent.setBounds(evt.getX() - BOX / 2, evt.getY() - BOX / 2, BOX, BOX);
  }

  /**
   * Implements an empty method for the <tt>MouseMotionListener</tt> interface.
   *
   * @param evt The associated mouse event.
   **/
  public void mouseMoved(MouseEvent evt) {}

  /**
   * Simple action listener for shape tool bar buttons that sets the drawing
   * frame's currently selected shape when receiving an action event.
   **/
  private class ShapeActionListener implements ActionListener {
    public void actionPerformed(ActionEvent evt) {
      selectShape(evt.getActionCommand());
    }
  }

  /**
   * This method actually performs the creation of the application window. It is
   * intended to be called by the Swing event thread and should not be called
   * directly.
   **/
  public static void main(String[] args) throws Exception {
    SwingUtilities.invokeAndWait(new Runnable() {
      public void run() {
        PaintFrame frame = new PaintFrame();
        frame.setDefaultCloseOperation(JFrame.DO_NOTHING_ON_CLOSE);
        frame.addWindowListener(new WindowAdapter() {
          public void windowClosing(WindowEvent evt) {
            System.exit(0);
          }
        });
        frame.addShape(new Circle());
        frame.addShape(new Square());
        frame.addShape(new Triangle());
        frame.setVisible(true);
      }
    });
  }
}

redpajama_set_name: RedPajamaGithub