there is substantial risk that if we are unable to renew our eea marketing authorization during any annual renewal cycle , or if our product label is materially restricted , or if study 041 does not provide the data necessary to maintain our marketing authorization , we would lose all , or a significant portion of , our ability to generate revenue from sales of translarna in the eea and other territories . translarna is an investigational new drug in the united states . during the first quarter of 2017 , we filed a new drug application , or nda , for translarna for the treatment of nmdmd over protest with the united states food and drug administration , or fda . in october 2017 , the office of drug evaluation i of the fda issued a complete response letter for the nda , stating that it was unable to approve the application in its current form . in response , we filed a formal dispute resolution request with the office of new drugs of the fda . in february 2018 , the office of new drugs of the fda denied our appeal of the complete response letter . in its response , the office of new drugs recommended a possible path forward for the ataluren nda submission based on the accelerated approval pathway . this would involve a re-submission of an nda containing the current data on effectiveness of ataluren with new data to be generated on dystrophin production in nmdmd patients ' muscles . we intend to follow the fda 's recommendation and will collect , using newer technologies via procedures and methods that we designed , such dystrophin data in a new study , study 045 , which we initiated in the fourth quarter of 2018. we expect that a potential re-submission of an nda could occur in mid-year 2020. additionally , should a re-submission of an nda receive accelerated approval , the office of new drugs stated that study 041 , which is currently enrolling , could serve as the confirmatory post-approval trial required in connection with the accelerated approval framework . 110 there is substantial risk that study 045 , or any other studies we may use to collect the dystrophin data , will not provide the necessary data to support a marketing approval for translarna for the treatment of nmdmd in the u.s. we hold the rights for the commercialization of tegsedi ( inotersen ) and waylivra ( volanesorsen ) for the treatment of rare diseases in countries in latin america and the caribbean pursuant to our collaboration and license agreement with akcea therapeutics , inc. , or akcea . tegsedi has received marketing authorization in the united states , eu and brazil for the treatment of stage 1 or stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis , or hattr amyloidosis . waylivra has received marketing authorization in the european union , or eu , for the treatment of familial chylomicronemia syndrome , or fcs . we anticipate filing for marketing authorization with anvisa in the second half of 2020. we have a pipeline of gene therapy product candidates for rare monogenic diseases that affect the central nervous system , or cns , including ptc-aadc for the treatment of aromatic l-amino acid decarboxylase , or aadc , deficiency , or aadc deficiency , a rare cns disorder arising from reductions in the enzyme aadc that result from mutations in the dopa decarboxylase gene . we are preparing a biologics license application , or bla , for ptc-aadc for the treatment of aadc deficiency in the united states , which we anticipate submitting to the fda in the second quarter of 2020. in january 2020 , we submitted a marketing authorization application , or maa , for ptc-aadc for the treatment of aadc deficiency in the eea to the ema and we expect an opinion from the committee for medicinal products for human use , or chmp , by the end of 2020. we also have a spinal muscular atrophy , or sma , collaboration with f. hoffman-la roche ltd. and hoffman-la roche inc. , which we refer to collectively as roche , and the spinal muscular atrophy foundation , or sma foundation . the lead compound in the sma program is risdiplam ( rg7916 , ro7034067 ) . roche submitted an nda for risdiplam to the fda in the fourth quarter of 2019 and the prescription drug user fee act , or pdufa , date for a decision by the fda is may 24 , 2020. risdiplam is expected to be indicated in the united states for sma type 1 , 2 and 3 patients , if approved . roche anticipates submitting an maa for risdiplam for the treatment of sma in the eea in mid-year 2020. in 2019 , we acquired substantially all of the assets of bioelectron technology corporation , or bioelectron , including certain compounds that we have begun to develop as part of our bio-e platform . in 2020 , we plan to initiate three trials in this platform with two unique compounds that regulate inflammation and oxidative stress . in addition , we have a pipeline of product candidates and discovery programs that are in early clinical , pre-clinical and research and development stages focused on the development of new treatments for multiple therapeutic areas , including rare diseases and oncology . overview—funding the success of our products and any other product candidates we may develop , depends largely on obtaining and maintaining reimbursement from governments and third-party insurers . during 2019 , our revenues were generated from sales of translarna for the treatment of nmdmd in countries where we were able to obtain acceptable commercial pricing and reimbursement terms and in select countries where we are permitted to distribute translarna under our eap programs , and from sales of emflaza for the treatment of dmd in the united states . story_separator_special_tag this is due to the numerous risks and uncertainties associated with developing drugs , including the uncertainty of : the scope , rate of progress and expense of our clinical trials and other research and development activities ; 114 the potential benefits of our product and product candidates over other therapies ; our ability to market , commercialize and achieve market acceptance for our product or any of our product candidates that we are developing or may develop in the future , including our ability to negotiate pricing and reimbursement terms acceptable to us ; clinical trial results ; the terms and timing of regulatory approvals ; and the expense of filing , prosecuting , defending and enforcing patent claims and other intellectual property rights . a change in the outcome of any of these variables with respect to the development of any of our products or product candidates could mean a significant change in the costs and timing associated with the development of that product candidates . for example , if the ema or fda or other regulatory authority were to require us to conduct clinical trials beyond those which we currently anticipate will be required for the completion of clinical development of any of our products or product candidate or if we experience significant delays in enrollment in any of our clinical trials , we could be required to expend significant additional financial resources and time on the completion of clinical development . selling , general and administrative expense selling , general and administrative expenses consist primarily of salaries and other related costs for personnel , including share-based compensation expenses , in our executive , legal , business development , finance , accounting , information technology and human resource functions . other selling , general and administrative expenses include facility-related costs not otherwise included in research and development expense ; advertising and promotional expenses ; costs associated with industry and trade shows ; and professional fees for legal services , including patent-related expenses , accounting services and miscellaneous selling costs . we expect that selling , general and administrative expenses will increase in future periods in connection with our continued efforts to commercialize our products , including increased payroll , expanded infrastructure , commercial operations , increased consulting , legal , accounting and investor relations expenses . interest expense , net interest expense , net consists of interest income earned on investments and interest expense from the convertible notes outstanding and interest expense from the credit agreement . critical accounting policies our management 's discussion and analysis of our financial condition and results of operations is based on our financial statements , which we have prepared in accordance with generally accepted accounting principles in the united states . the preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements , as well as the reported revenues and expenses during the reporting periods . actual results may differ from these estimates under different assumptions or conditions . of our policies , the following are considered critical to an understanding of our consolidated financial statements as they require the application of the most subjective and complex judgment , involving critical accounting estimates and assumptions impacting our consolidated financial statements : revenue recognition convertible notes offering income taxes business combinations and asset acquisitions indefinite-lived intangible assets revenue recognition in may 2014 , the financial accounting standards board ( “ fasb ” ) issued accounting standards update ( “ asu ” ) no . 2014-9 , “ revenue from contracts with customers ( topic 606 ) ” . asu no . 2014-9 eliminated transaction- and industry-specific revenue recognition guidance under fasb accounting standards codification ( “ asc ” ) subtopic 605-15 , revenue recognition-products ( topic 605 ) and replaced it with a principle-based approach for determining revenue recognition . asc topic 606 requires 115 entities to recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services . on january 1 , 2018 , we adopted asc topic 606 using the modified retrospective approach , a practical expedient permitted under topic 606 , and applied this approach only to contracts that were not completed as of january 1 , 2018. we calculated a one-time transition adjustment of $ 3.3 million , which was recorded on january 1 , 2018 to the opening balance of accumulated deficit , related to the product sales of emflaza . the asc 606 transition adjustment recorded for emflaza resulted in sales being recognized earlier than under topic 605 , as the deferred revenue recognition model ( sell-through ) is not allowed under topic 606. the one-time adjustment consisted of $ 3.9 million in deferred revenue offset by $ 0.6 million of variable consideration . the information presented for the periods prior to january 1 , 2018 has not been adjusted and is reported under topic 605. periods prior to january 1 , 2018 we recognize revenue when amounts are realized or realizable and earned . revenue is considered realizable and earned when the following criteria are met : ( 1 ) persuasive evidence of an arrangement exists ; ( 2 ) delivery has occurred or services have been rendered ; ( 3 ) the price is fixed or determinable ; and ( 4 ) collection of the amounts due are reasonably assured . net product sales prior to the second quarter of 2017 , our net product sales have consisted primarily of sales of translarna for the treatment of nmdmd in territories outside of the u.s. we recognize revenue from product sales when there is persuasive evidence that an arrangement exists , title to product and associated risk of loss has passed to the customer ,

sources of liquidity since inception , we have incurred significant operating losses . as a growing commercial-stage biopharmaceutical company , we are engaging in significant commercialization efforts for our products while also devoting a substantial portion of our efforts on research and development related to our products , product candidates and other programs . to date , almost all of our product revenue has been attributable to sales of translarna for the treatment of nmdmd in territories outside of the united states and from emflaza for the treatment of dmd in the united states . our ongoing ability to generate revenue from sales of translarna for the treatment of nmdmd is dependent upon our ability to maintain our marketing authorization in brazil and in the eea and secure market access through commercial programs following the conclusion of pricing and reimbursement terms at sustainable levels in the member states of the eea or through eap programs in the eea and other territories . the marketing authorization requires annual review and renewal by the european commission following reassessment by the ema of the benefit-risk balance of the authorization and is subject to the specific obligation to 122 conduct study 041. our ability to generate product revenue from emflaza will largely depend on the coverage and reimbursement levels set by governmental authorities , private health insurers and other third-party payors . on august 23 , 2018 , we completed our acquisition of agilis for total upfront consideration comprised of $ 49.2 million in cash and 3,500,907 shares of our common stock , which was determined by dividing $ 150.0 million by the volume-weighted average price per share of our common stock on nasdaq for the 10 consecutive trading-day period ending on the second trading-day immediately preceding the closing . agilis equityholders may become entitled to receive contingent payments from us based on the achievement of certain development , regulatory and net sales milestones as well as based upon a percentage of net sales of certain products .


 Write a concise suspicious activity report of the following text delimited by triple backquotes. Return your response as a formal report which covers the key points highlighting the location,dates,entity names and account holder information in chronological order of the text.
     ```sources of liquidity since inception , we have incurred significant operating losses . as a growing commercial-stage biopharmaceutical company , we are engaging in significant commercialization efforts for our products while also devoting a substantial portion of our efforts on research and development related to our products , product candidates and other programs . to date , almost all of our product revenue has been attributable to sales of translarna for the treatment of nmdmd in territories outside of the united states and from emflaza for the treatment of dmd in the united states . our ongoing ability to generate revenue from sales of translarna for the treatment of nmdmd is dependent upon our ability to maintain our marketing authorization in brazil and in the eea and secure market access through commercial programs following the conclusion of pricing and reimbursement terms at sustainable levels in the member states of the eea or through eap programs in the eea and other territories . the marketing authorization requires annual review and renewal by the european commission following reassessment by the ema of the benefit-risk balance of the authorization and is subject to the specific obligation to 122 conduct study 041. our ability to generate product revenue from emflaza will largely depend on the coverage and reimbursement levels set by governmental authorities , private health insurers and other third-party payors . on august 23 , 2018 , we completed our acquisition of agilis for total upfront consideration comprised of $ 49.2 million in cash and 3,500,907 shares of our common stock , which was determined by dividing $ 150.0 million by the volume-weighted average price per share of our common stock on nasdaq for the 10 consecutive trading-day period ending on the second trading-day immediately preceding the closing . agilis equityholders may become entitled to receive contingent payments from us based on the achievement of certain development , regulatory and net sales milestones as well as based upon a percentage of net sales of certain products .
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 Suspicious Activity Report : there is substantial risk that if we are unable to renew our eea marketing authorization during any annual renewal cycle , or if our product label is materially restricted , or if study 041 does not provide the data necessary to maintain our marketing authorization , we would lose all , or a significant portion of , our ability to generate revenue from sales of translarna in the eea and other territories . translarna is an investigational new drug in the united states . during the first quarter of 2017 , we filed a new drug application , or nda , for translarna for the treatment of nmdmd over protest with the united states food and drug administration , or fda . in october 2017 , the office of drug evaluation i of the fda issued a complete response letter for the nda , stating that it was unable to approve the application in its current form . in response , we filed a formal dispute resolution request with the office of new drugs of the fda . in february 2018 , the office of new drugs of the fda denied our appeal of the complete response letter . in its response , the office of new drugs recommended a possible path forward for the ataluren nda submission based on the accelerated approval pathway . this would involve a re-submission of an nda containing the current data on effectiveness of ataluren with new data to be generated on dystrophin production in nmdmd patients ' muscles . we intend to follow the fda 's recommendation and will collect , using newer technologies via procedures and methods that we designed , such dystrophin data in a new study , study 045 , which we initiated in the fourth quarter of 2018. we expect that a potential re-submission of an nda could occur in mid-year 2020. additionally , should a re-submission of an nda receive accelerated approval , the office of new drugs stated that study 041 , which is currently enrolling , could serve as the confirmatory post-approval trial required in connection with the accelerated approval framework . 110 there is substantial risk that study 045 , or any other studies we may use to collect the dystrophin data , will not provide the necessary data to support a marketing approval for translarna for the treatment of nmdmd in the u.s. we hold the rights for the commercialization of tegsedi ( inotersen ) and waylivra ( volanesorsen ) for the treatment of rare diseases in countries in latin america and the caribbean pursuant to our collaboration and license agreement with akcea therapeutics , inc. , or akcea . tegsedi has received marketing authorization in the united states , eu and brazil for the treatment of stage 1 or stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis , or hattr amyloidosis . waylivra has received marketing authorization in the european union , or eu , for the treatment of familial chylomicronemia syndrome , or fcs . we anticipate filing for marketing authorization with anvisa in the second half of 2020. we have a pipeline of gene therapy product candidates for rare monogenic diseases that affect the central nervous system , or cns , including ptc-aadc for the treatment of aromatic l-amino acid decarboxylase , or aadc , deficiency , or aadc deficiency , a rare cns disorder arising from reductions in the enzyme aadc that result from mutations in the dopa decarboxylase gene . we are preparing a biologics license application , or bla , for ptc-aadc for the treatment of aadc deficiency in the united states , which we anticipate submitting to the fda in the second quarter of 2020. in january 2020 , we submitted a marketing authorization application , or maa , for ptc-aadc for the treatment of aadc deficiency in the eea to the ema and we expect an opinion from the committee for medicinal products for human use , or chmp , by the end of 2020. we also have a spinal muscular atrophy , or sma , collaboration with f. hoffman-la roche ltd. and hoffman-la roche inc. , which we refer to collectively as roche , and the spinal muscular atrophy foundation , or sma foundation . the lead compound in the sma program is risdiplam ( rg7916 , ro7034067 ) . roche submitted an nda for risdiplam to the fda in the fourth quarter of 2019 and the prescription drug user fee act , or pdufa , date for a decision by the fda is may 24 , 2020. risdiplam is expected to be indicated in the united states for sma type 1 , 2 and 3 patients , if approved . roche anticipates submitting an maa for risdiplam for the treatment of sma in the eea in mid-year 2020. in 2019 , we acquired substantially all of the assets of bioelectron technology corporation , or bioelectron , including certain compounds that we have begun to develop as part of our bio-e platform . in 2020 , we plan to initiate three trials in this platform with two unique compounds that regulate inflammation and oxidative stress . in addition , we have a pipeline of product candidates and discovery programs that are in early clinical , pre-clinical and research and development stages focused on the development of new treatments for multiple therapeutic areas , including rare diseases and oncology . overview—funding the success of our products and any other product candidates we may develop , depends largely on obtaining and maintaining reimbursement from governments and third-party insurers . during 2019 , our revenues were generated from sales of translarna for the treatment of nmdmd in countries where we were able to obtain acceptable commercial pricing and reimbursement terms and in select countries where we are permitted to distribute translarna under our eap programs , and from sales of emflaza for the treatment of dmd in the united states . story_separator_special_tag this is due to the numerous risks and uncertainties associated with developing drugs , including the uncertainty of : the scope , rate of progress and expense of our clinical trials and other research and development activities ; 114 the potential benefits of our product and product candidates over other therapies ; our ability to market , commercialize and achieve market acceptance for our product or any of our product candidates that we are developing or may develop in the future , including our ability to negotiate pricing and reimbursement terms acceptable to us ; clinical trial results ; the terms and timing of regulatory approvals ; and the expense of filing , prosecuting , defending and enforcing patent claims and other intellectual property rights . a change in the outcome of any of these variables with respect to the development of any of our products or product candidates could mean a significant change in the costs and timing associated with the development of that product candidates . for example , if the ema or fda or other regulatory authority were to require us to conduct clinical trials beyond those which we currently anticipate will be required for the completion of clinical development of any of our products or product candidate or if we experience significant delays in enrollment in any of our clinical trials , we could be required to expend significant additional financial resources and time on the completion of clinical development . selling , general and administrative expense selling , general and administrative expenses consist primarily of salaries and other related costs for personnel , including share-based compensation expenses , in our executive , legal , business development , finance , accounting , information technology and human resource functions . other selling , general and administrative expenses include facility-related costs not otherwise included in research and development expense ; advertising and promotional expenses ; costs associated with industry and trade shows ; and professional fees for legal services , including patent-related expenses , accounting services and miscellaneous selling costs . we expect that selling , general and administrative expenses will increase in future periods in connection with our continued efforts to commercialize our products , including increased payroll , expanded infrastructure , commercial operations , increased consulting , legal , accounting and investor relations expenses . interest expense , net interest expense , net consists of interest income earned on investments and interest expense from the convertible notes outstanding and interest expense from the credit agreement . critical accounting policies our management 's discussion and analysis of our financial condition and results of operations is based on our financial statements , which we have prepared in accordance with generally accepted accounting principles in the united states . the preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements , as well as the reported revenues and expenses during the reporting periods . actual results may differ from these estimates under different assumptions or conditions . of our policies , the following are considered critical to an understanding of our consolidated financial statements as they require the application of the most subjective and complex judgment , involving critical accounting estimates and assumptions impacting our consolidated financial statements : revenue recognition convertible notes offering income taxes business combinations and asset acquisitions indefinite-lived intangible assets revenue recognition in may 2014 , the financial accounting standards board ( “ fasb ” ) issued accounting standards update ( “ asu ” ) no . 2014-9 , “ revenue from contracts with customers ( topic 606 ) ” . asu no . 2014-9 eliminated transaction- and industry-specific revenue recognition guidance under fasb accounting standards codification ( “ asc ” ) subtopic 605-15 , revenue recognition-products ( topic 605 ) and replaced it with a principle-based approach for determining revenue recognition . asc topic 606 requires 115 entities to recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services . on january 1 , 2018 , we adopted asc topic 606 using the modified retrospective approach , a practical expedient permitted under topic 606 , and applied this approach only to contracts that were not completed as of january 1 , 2018. we calculated a one-time transition adjustment of $ 3.3 million , which was recorded on january 1 , 2018 to the opening balance of accumulated deficit , related to the product sales of emflaza . the asc 606 transition adjustment recorded for emflaza resulted in sales being recognized earlier than under topic 605 , as the deferred revenue recognition model ( sell-through ) is not allowed under topic 606. the one-time adjustment consisted of $ 3.9 million in deferred revenue offset by $ 0.6 million of variable consideration . the information presented for the periods prior to january 1 , 2018 has not been adjusted and is reported under topic 605. periods prior to january 1 , 2018 we recognize revenue when amounts are realized or realizable and earned . revenue is considered realizable and earned when the following criteria are met : ( 1 ) persuasive evidence of an arrangement exists ; ( 2 ) delivery has occurred or services have been rendered ; ( 3 ) the price is fixed or determinable ; and ( 4 ) collection of the amounts due are reasonably assured . net product sales prior to the second quarter of 2017 , our net product sales have consisted primarily of sales of translarna for the treatment of nmdmd in territories outside of the u.s. we recognize revenue from product sales when there is persuasive evidence that an arrangement exists , title to product and associated risk of loss has passed to the customer ,

