Biotek-snakken — December 2020
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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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leading transplantation centers initially in countries with early patient access and reimbursement is possible. Also, since imlifidase is a paradigm shift in transplantation and probably the most innovative drug in this areas for the last 20-30 years we need to navigate local legislative systems and allocation systems. So don’t expect a large roll out like a traditional launch process also because we got approv
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al on phase 2 data, we need to conduct a post approval study in parallel in the absent of a full phase 3 study.
Lastly, the thinking behind this is also that clinics and clinicians will be monitored very closely so we ensure that the product is used according to protocol and the first clinics gain positive experience and follow-up data. It is critical for the long term success of our technology that is being used as intended so we don’t risk the product potentially being withdrawn from the m
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