Biotek-snakken — December 2020
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Our View
We had looked forward to March 17, and believe we share the initial disappointment with the management team and investors on this delay. In the press release, we learn that Orphazyme has “responded to all FDA information requests and submitted all outstanding information regarding the arimoclomol NDA for NPC.” It also encompasses the crucial QTc clinical data. Thus, we see a small risk for additional delays. Based on the arguments below, we even believe that a potential decision by the -
Background
The FDA has extended the NDA review period for arimoclomol in Niemann-Pick Disease (NPC) with a standard 90 days extension. The NDA remains under Priority Review, and the extension does not impact the eligibility for a potential Priority Review Voucher (PRV). The updated PDUFA date is set to June 17, 2021, extended from previously March 17, 2021. -
Orphazyme: Our View to the Regulatory Update in NPCRedeye Research Note 2020/12/28
Redeye reiterates its probability rate for arimoclomol in NPC. While the extended NDA review, from previously March 17, 2021, updated to June 17, 2021, is initially disappointing, we also note that all outstanding information has now been submitted to the FDA. We consequently see a small risk for additional delays. -
Orphazyme:
Nedenfor den slags "colour" som jeg efterspurgte - Redeye sendte buy ud i sidste uge. -
velbekomme
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velbekomme
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Velbekomme
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@Lexus- de skriver chf 287. Sikkert en fejl, det skulle nok være Skr. 287. Men ret interresant at RBC (Royal Bank of Canada) både har Hansa og Genmab i deres biotek toppick for 2021.
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Hansa Jeg spurgte primo dec om de ville komme med IR når de har doseret første patient her i EU. Herunder svar: We are preparing the launch activities in select countries as we speak and expect to communicate around the launch as indicated in our milestones. This is typically how healthcare companies communicate rather than first commercial sale (accounting related) or first dosing (more study related). As we have communicated it will be a very targeted launch focusing on a few but leading trans
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