Biotek-snakken — December 2020
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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the long term success of our technology that is being used as intended so we don’t risk the product potentially being withdrawn from the m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?
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Uha,, så skulle jeg have købt dem til aktiesparekontoen idag ,,, men har dem heldigvis også i den frie beholdning
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Tak for god debat i år ! Det har været et usædvanligt godt år hvor selve Genmab trækker ned i den samlede PF. Meget af årets gevinst kom hjem på AZT med 1200% stigning. Hvad var jeres højdespinger ? Har store forventninger i 2021 til STRO, ZYME, MYOV og CHMA. Bliver det i 2021 at antibiotics flyver ? Super goneré og andet snask presse på - God nyt Nytår og husk beskyttelse
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Det her:
BioPorto Diagnostics A / S (BioPorto) annoncerer selvdeklarationen (CE-mærkning) i Europa tekst i dette link: https://finance.yahoo.com/news/bioporto-announces-ce-mark-near-145700813.html Hvor eneste jeg kan genkende er selvdeklarationen, som korrekt? En der ved hvad der er godkendt? Og hvis kun nyrerelateret godkendelse, så hvordan er covid koblet på? Jeg fornemmede allerede for et godt styklke tid siden at den kunne komme som et springvand i en ørken? Er det hvad sker lige nu? -
Så når kl.: 16:36 Bioporto får CE-godkendt nnn? Er det kun indirekte, og Bioporto selvdeklarerer sig! Det er korrekt at det er både er lovligt og korrekt, hvis optionerne for CE mærkningen er til stede! Det går jeg stærkt ud fra de er, så det er IKKE mit spørgsmål! Men hvad er det, der er godkendt? Det er mit spørgsmål? CE i sig selv er IKKE engodkendelse!
Det må være noget med en årsgevinst som skal trimmes...
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