Biotek-snakken — December 2020
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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the long term success of our technology that is being used as intended so we don’t risk the product potentially being withdrawn from the m
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market because someone is using it off-label or in the wrong patients.
Hope this helps clarify our launch strategy
Best
Klaus
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fra 28/12 - havde ikke set den: Orphazyme Buy Reiterated at BofA as FDA Review Extension Was Expected
(PLX AI) – Orphazyme three-months extension on FDA's review of arimoclomol was expected and not a reason to change a buy recommendation, Bank of America analysts said. <br/>• Orphazyme said yesterday the FDA extended the review period of the New Drug Application (NDA) for arimoclomol for the treatment of Niemann-Pick Disease Type C (NPC) by three months June 17<br/>• FDA needs additional time -
to complete its review of the hepatic, renal and QTc data that it requested and has begun discussions with the company on the labeling and safety data, with no issues raised so far, BofA said<br/>• The drug has a supportive efficacy and safety profile in a disease with limited treatment options: BofA<br/>• BofA recommendation maintained at buy, with price target $13
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helt enig og tak - udover teknisk svag måske noget skatteteknisk salg ultimo?
Det må være noget med en årsgevinst som skal trimmes...
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