the fda has granted a standard review for the nda and has set a target review date under the prescription drug user fee act , or pdufa , of october 24 , 2017. the pdufa date is the goal date for the fda to complete its review of the nda , however , such date is not binding on the agency and there can be no assurance that the fda will complete its review of our nda by the pdufa goal date . filing over protest is a procedural path permitted by fda regulations that allows a company to have its nda filed and reviewed when there is a disagreement with regulators over the acceptability of the nda submission . the nda , which seeks approval of translarna for the treatment of nmdmd in the united states , was initially submitted by us in december 2015. in february 2016 , following our initial submission , we received a refuse to file letter from the fda stating that our nda was not sufficiently complete to permit a substantive review . specifically , we were notified in the letter that , in the view of the fda , both the phase 2b and phase 3 act dmd trials were negative and do not provide substantial evidence of effectiveness and that our nda did not contain adequate information regarding the abuse potential of translarna . additionally , the fda stated that we had proposed a post-hoc adjustment of act dmd that eliminates data from a majority of enrolled patients . during july 2016 , we appealed the refuse to file decision via the fda 's formal dispute resolution process , however , this appeal was denied by the fda 's office of drug evaluation i in october 2016. there is significant risk that , notwithstanding any dialogue we have had or any further dialogue we may be able to initiate with the fda , pursuant to the file over protest process or otherwise , the agency will continue to disagree with our interpretation of the results of act dmd and the totality of clinical data from our trials , and will not grant marketing approval for translarna for the treatment of nmdmd . in march 2016 , following receipt of the refuse to file letter , we commenced implementation of a reorganization of our operations intended to improve efficiency and better align our costs and employment structure with our strategic plans . we completed the reorganization in june 2016 and recorded a one-time charge of $ 2.5 million for the year ended december 31 , 2016 for severance and related workforce reduction expenses . 84 on march 2 , 2017 , we announced that the primary and secondary endpoints were not achieved in act cf , our phase 3 double-blind , placebo-controlled , 48-week clinical trial comparing translarna to placebo in nmcf patients six years of age or older not receiving chronic inhaled aminoglycosides . the safety profile of translarna in the act cf study was consistent with previous studies and no new safety signals were identified . based on the results of act cf , we plan to discontinue our current clinical development of translarna for nmcf and close ongoing extension studies of translarna for the treatment of nmcf . we have withdrawn our type ii variation submission with the ema , which sought approval of translarna for the treatment of nmcf in the eea . based on its understood mechanism of action , we believe that translarna may have benefit in the treatment of patients with genetic disorders that arise as a result of a nonsense mutation . we are pursuing studies for translarna in additional indications : mucopolysaccharidosis type i caused by nonsense mutation , or nmmps i , nonsense mutation aniridia , and nonsense mutation dravet syndrome/cdkl5 . we continue to advance the development of our 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 . sunfish , a two-part clinical study in pediatric and adult type 2 and type 3 sma patients initiated in the fourth quarter of 2016 , followed by the initiation of firefish , a two-part clinical study in infants with type 1 sma . both sunfish and firefish are investigating the safety , tolerability and efficacy of the compound rg7916 in the applicable patient populations . part one of each study is a dose-finding study with the primary objectives of evaluating the safety , pharmacokinetics , or pk , and pharmacodynamics of rg7916 in patients and to select the dose for part two of the applicable study . part one of each study is expected to be followed by a pivotal part two with the primary objective of evaluating the efficacy of rg7916 . commencement of the pivotal part two portion of either sunfish or firefish will trigger a single $ 20 million milestone payment to us from roche . we anticipate that both sunfish and firefish will move into the pivotal second part of the respective study during 2017. in addition , we have a pipeline of product candidates that are in early clinical and preclinical development . a phase 1 first-in-human , dose-escalation safety and pk open-label clinical study for our product candidate , ptc596 , in advanced cancer patients with solid tumors recently completed . data from this study is expected during 2017. on march 16 , 2017 , we announced that we have entered into an asset purchase agreement with marathon pharmaceuticals , llc , under which we have agreed to acquire all rights to emflaza tm ( deflazacort ) , subject to the satisfaction or waiver of certain conditions . emflaza received approval from the fda on february 9 , 2017 as a treatment of duchenne muscular dystrophy in patients five years of age and older . story_separator_special_tag if not substantive , the contingent consideration is allocated to the existing units of accounting based on relative selling price and recognized following the same basis previously established for the associated unit of accounting . we recognize reimbursements for research and development costs under collaboration agreements as revenue as the services are performed . we record these reimbursements as revenue and not as a reduction of research and development expenses as we have the risks and rewards as the principal in the research and development activities . our principal obligation under our grant agreements is to conduct the internal or external research in the specific field funded by the grant . we determine , through the grant 's normal research process , which research and development projects to pursue . we recognize grant revenues as the research activities are performed . if the grant includes an upfront payment , we defer the amount and recognize it as revenue as the expenditures are incurred . inventories and cost of product revenues in 2014 , we were notified that the european commission granted marketing authorization for translarna for the treatment of nmdmd in ambulatory patients aged five years and older . the conditional marketing authorization allows us to market translarna for the treatment of nmdmd in the 31 member states of the eea . our launch in these countries is on a country by country basis . this marketing authorization is subject to annual review and renewal by the european commission following reassessment by the ema of the benefit-risk balance of the authorization , as well as our satisfaction of any specific obligation or other requirement placed upon the marketing authorization , including conducting and reporting results from study 041 , as described below . in january 2016 , we submitted the final clinical study report from act dmd to the ema in fulfillment of the initial specific obligation placed on our marketing authorization . the primary efficacy endpoint of act dmd was not achieved with statistical significance . we made our submission to the ema as a type ii variation request that sought to have this initial specific obligation to our marketing authorization removed and a full marketing authorization granted . in february 2016 , we also submitted a marketing authorization renewal request with the ema . in january 2017 , the european commission renewed our marketing authorization , subject to the specific obligation to conduct study 041. because the ema did not grant our request for full marketing authorization , the authorization remains subject to annual ema reassessment . the last granted marketing authorization renewal is effective , unless extended , through august 5 , 2017. we submitted a marketing authorization renewal request to the ema in february 2017. we plan to seek to renew the marketing authorization on an annual basis until a marketing authorization that is not subject to any specific obligation is granted , if ever . if , in any annual renewal cycle , the ema determines that the balance of benefits and risks of using translarna for the treatment of nmdmd has changed materially or that we have not or are unable to comply with any specific obligation or other requirement that has been or may be placed on the marketing authorization , the european commission could , at the ema 's recommendation , vary , suspend , withdraw or refuse to renew the marketing authorization for translarna or impose other specific obligations or restrictions on the marketing authorization . although there continues to be substantial risk that regulators could , in the future , suspend or not renew our marketing authorization in the eea for translarna for the treatment of nmdmd , we have determined that we will capitalize inventory with respect to the translarna finished product for commercial use effective january 1 , 2017 and commence the expensing of 89 cost of goods sold based on the marketing authorization renewal granted by the ec . had we capitalized as inventory all of our translarna product that is available for commercial sale on hand as of december 31 , 2016 , the value of that inventory would have been approximately $ 1.7 million . in addition , had we expensed the cost of translarna product sold as a cost of sales , the gross profit margin would have been greater than 90 % , which we believe is consistent with the cost of producing small molecule therapeutics for orphan drug diseases in the pharmaceutical industry . accrued expenses as part of the process of preparing our financial statements , we are required to estimate accrued expenses . this process involves communicating with our applicable personnel to identify services that have been performed on our behalf and estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of actual cost . the majority of our service providers invoice us monthly in arrears for services performed . we make estimates of our accrued expenses as of each balance sheet date in our financial statements based on facts and circumstances known to us . examples of estimated accrued expenses include : fees paid to contract research organizations in connection with preclinical and toxicology studies and clinical trials ; fees paid to investigative sites in connection with clinical trials ; fees paid to contract manufacturers in connection with the production of clinical trial materials ; and professional service fees . share-based compensation we expect to grant additional stock options that will result in additional share-based compensation expense . we measure the cost of employee services received in exchange for an award of equity instruments based on the grant date fair value of the award . for service type awards , share-based compensation expense is recognized on a straight-line basis over the period during which the employee is required to provide service in exchange for the entire award . for awards that vest or begin

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 translarna for nmdmd while also devoting a substantial portion of our efforts on research and development programs related to translarna and our other product candidates . to date , all of our product revenue has been attributable to sales of translarna for the treatment of nmdmd in territories outside of 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 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 conduct study 041. we have historically financed our operations primarily through the issuance and sale of our common stock in public offerings , the private placements of our preferred stock , collaborations , bank debt , convertible debt financings and grants and clinical trial support from governmental and philanthropic organizations and patient advocacy groups in the disease areas addressed by our product candidates . we expect to continue to incur significant expenses and operating losses for at least the next several years . the net losses we incur may fluctuate significantly from quarter to quarter .


 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 translarna for nmdmd while also devoting a substantial portion of our efforts on research and development programs related to translarna and our other product candidates . to date , all of our product revenue has been attributable to sales of translarna for the treatment of nmdmd in territories outside of 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 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 conduct study 041. we have historically financed our operations primarily through the issuance and sale of our common stock in public offerings , the private placements of our preferred stock , collaborations , bank debt , convertible debt financings and grants and clinical trial support from governmental and philanthropic organizations and patient advocacy groups in the disease areas addressed by our product candidates . we expect to continue to incur significant expenses and operating losses for at least the next several years . the net losses we incur may fluctuate significantly from quarter to quarter .
```    
 Suspicious Activity Report : the fda has granted a standard review for the nda and has set a target review date under the prescription drug user fee act , or pdufa , of october 24 , 2017. the pdufa date is the goal date for the fda to complete its review of the nda , however , such date is not binding on the agency and there can be no assurance that the fda will complete its review of our nda by the pdufa goal date . filing over protest is a procedural path permitted by fda regulations that allows a company to have its nda filed and reviewed when there is a disagreement with regulators over the acceptability of the nda submission . the nda , which seeks approval of translarna for the treatment of nmdmd in the united states , was initially submitted by us in december 2015. in february 2016 , following our initial submission , we received a refuse to file letter from the fda stating that our nda was not sufficiently complete to permit a substantive review . specifically , we were notified in the letter that , in the view of the fda , both the phase 2b and phase 3 act dmd trials were negative and do not provide substantial evidence of effectiveness and that our nda did not contain adequate information regarding the abuse potential of translarna . additionally , the fda stated that we had proposed a post-hoc adjustment of act dmd that eliminates data from a majority of enrolled patients . during july 2016 , we appealed the refuse to file decision via the fda 's formal dispute resolution process , however , this appeal was denied by the fda 's office of drug evaluation i in october 2016. there is significant risk that , notwithstanding any dialogue we have had or any further dialogue we may be able to initiate with the fda , pursuant to the file over protest process or otherwise , the agency will continue to disagree with our interpretation of the results of act dmd and the totality of clinical data from our trials , and will not grant marketing approval for translarna for the treatment of nmdmd . in march 2016 , following receipt of the refuse to file letter , we commenced implementation of a reorganization of our operations intended to improve efficiency and better align our costs and employment structure with our strategic plans . we completed the reorganization in june 2016 and recorded a one-time charge of $ 2.5 million for the year ended december 31 , 2016 for severance and related workforce reduction expenses . 84 on march 2 , 2017 , we announced that the primary and secondary endpoints were not achieved in act cf , our phase 3 double-blind , placebo-controlled , 48-week clinical trial comparing translarna to placebo in nmcf patients six years of age or older not receiving chronic inhaled aminoglycosides . the safety profile of translarna in the act cf study was consistent with previous studies and no new safety signals were identified . based on the results of act cf , we plan to discontinue our current clinical development of translarna for nmcf and close ongoing extension studies of translarna for the treatment of nmcf . we have withdrawn our type ii variation submission with the ema , which sought approval of translarna for the treatment of nmcf in the eea . based on its understood mechanism of action , we believe that translarna may have benefit in the treatment of patients with genetic disorders that arise as a result of a nonsense mutation . we are pursuing studies for translarna in additional indications : mucopolysaccharidosis type i caused by nonsense mutation , or nmmps i , nonsense mutation aniridia , and nonsense mutation dravet syndrome/cdkl5 . we continue to advance the development of our 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 . sunfish , a two-part clinical study in pediatric and adult type 2 and type 3 sma patients initiated in the fourth quarter of 2016 , followed by the initiation of firefish , a two-part clinical study in infants with type 1 sma . both sunfish and firefish are investigating the safety , tolerability and efficacy of the compound rg7916 in the applicable patient populations . part one of each study is a dose-finding study with the primary objectives of evaluating the safety , pharmacokinetics , or pk , and pharmacodynamics of rg7916 in patients and to select the dose for part two of the applicable study . part one of each study is expected to be followed by a pivotal part two with the primary objective of evaluating the efficacy of rg7916 . commencement of the pivotal part two portion of either sunfish or firefish will trigger a single $ 20 million milestone payment to us from roche . we anticipate that both sunfish and firefish will move into the pivotal second part of the respective study during 2017. in addition , we have a pipeline of product candidates that are in early clinical and preclinical development . a phase 1 first-in-human , dose-escalation safety and pk open-label clinical study for our product candidate , ptc596 , in advanced cancer patients with solid tumors recently completed . data from this study is expected during 2017. on march 16 , 2017 , we announced that we have entered into an asset purchase agreement with marathon pharmaceuticals , llc , under which we have agreed to acquire all rights to emflaza tm ( deflazacort ) , subject to the satisfaction or waiver of certain conditions . emflaza received approval from the fda on february 9 , 2017 as a treatment of duchenne muscular dystrophy in patients five years of age and older . story_separator_special_tag if not substantive , the contingent consideration is allocated to the existing units of accounting based on relative selling price and recognized following the same basis previously established for the associated unit of accounting . we recognize reimbursements for research and development costs under collaboration agreements as revenue as the services are performed . we record these reimbursements as revenue and not as a reduction of research and development expenses as we have the risks and rewards as the principal in the research and development activities . our principal obligation under our grant agreements is to conduct the internal or external research in the specific field funded by the grant . we determine , through the grant 's normal research process , which research and development projects to pursue . we recognize grant revenues as the research activities are performed . if the grant includes an upfront payment , we defer the amount and recognize it as revenue as the expenditures are incurred . inventories and cost of product revenues in 2014 , we were notified that the european commission granted marketing authorization for translarna for the treatment of nmdmd in ambulatory patients aged five years and older . the conditional marketing authorization allows us to market translarna for the treatment of nmdmd in the 31 member states of the eea . our launch in these countries is on a country by country basis . this marketing authorization is subject to annual review and renewal by the european commission following reassessment by the ema of the benefit-risk balance of the authorization , as well as our satisfaction of any specific obligation or other requirement placed upon the marketing authorization , including conducting and reporting results from study 041 , as described below . in january 2016 , we submitted the final clinical study report from act dmd to the ema in fulfillment of the initial specific obligation placed on our marketing authorization . the primary efficacy endpoint of act dmd was not achieved with statistical significance . we made our submission to the ema as a type ii variation request that sought to have this initial specific obligation to our marketing authorization removed and a full marketing authorization granted . in february 2016 , we also submitted a marketing authorization renewal request with the ema . in january 2017 , the european commission renewed our marketing authorization , subject to the specific obligation to conduct study 041. because the ema did not grant our request for full marketing authorization , the authorization remains subject to annual ema reassessment . the last granted marketing authorization renewal is effective , unless extended , through august 5 , 2017. we submitted a marketing authorization renewal request to the ema in february 2017. we plan to seek to renew the marketing authorization on an annual basis until a marketing authorization that is not subject to any specific obligation is granted , if ever . if , in any annual renewal cycle , the ema determines that the balance of benefits and risks of using translarna for the treatment of nmdmd has changed materially or that we have not or are unable to comply with any specific obligation or other requirement that has been or may be placed on the marketing authorization , the european commission could , at the ema 's recommendation , vary , suspend , withdraw or refuse to renew the marketing authorization for translarna or impose other specific obligations or restrictions on the marketing authorization . although there continues to be substantial risk that regulators could , in the future , suspend or not renew our marketing authorization in the eea for translarna for the treatment of nmdmd , we have determined that we will capitalize inventory with respect to the translarna finished product for commercial use effective january 1 , 2017 and commence the expensing of 89 cost of goods sold based on the marketing authorization renewal granted by the ec . had we capitalized as inventory all of our translarna product that is available for commercial sale on hand as of december 31 , 2016 , the value of that inventory would have been approximately $ 1.7 million . in addition , had we expensed the cost of translarna product sold as a cost of sales , the gross profit margin would have been greater than 90 % , which we believe is consistent with the cost of producing small molecule therapeutics for orphan drug diseases in the pharmaceutical industry . accrued expenses as part of the process of preparing our financial statements , we are required to estimate accrued expenses . this process involves communicating with our applicable personnel to identify services that have been performed on our behalf and estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of actual cost . the majority of our service providers invoice us monthly in arrears for services performed . we make estimates of our accrued expenses as of each balance sheet date in our financial statements based on facts and circumstances known to us . examples of estimated accrued expenses include : fees paid to contract research organizations in connection with preclinical and toxicology studies and clinical trials ; fees paid to investigative sites in connection with clinical trials ; fees paid to contract manufacturers in connection with the production of clinical trial materials ; and professional service fees . share-based compensation we expect to grant additional stock options that will result in additional share-based compensation expense . we measure the cost of employee services received in exchange for an award of equity instruments based on the grant date fair value of the award . for service type awards , share-based compensation expense is recognized on a straight-line basis over the period during which the employee is required to provide service in exchange for the entire award . for awards that vest or begin

