MisterBlues schreef op 22 oktober 2020 12:23:
Wie wil dit uitzoeken?:
As an FDA rule if an endpoint demonstrates a greater than 30% improvement in efficacy over an existing therapy is likely approvable. When there are no approved therapies as in the case of COVID-19 the bar is 20%. $RLFTF Aviptadil in great shape at 81% survival vs. 17% placebo. Not a matter of if people it is when.MisterBlues schreef op 17 oktober 2020 11:24:
Voor de liefhebbers (en handig om deze link te hebben voor later).
The FDA has more than 50 regulatory pathways available to companies hoping to get a new drug or biologic approved. Here are the 22 that are most likely to be used to help bring new COVID-19 products to patients.
Alexander Gaffney is the author of this piece (agaffney@agencyiq.com)
agencyiq.com/the-twenty-two-regulator...