This posting was based on a misunderstanding of the FDA (and EU) approval process, and therefore I have rewritten it. The rewritten version was posted 30-Jan-2010 with the title "Andromedia's DiaPep 277 Preps for Second Phase-III Trial". I'm very sorry for the misunderstanding. Please read the updated version for the current research status.
Joshua Levy
3 comments:
Basic misunderstanding of the basic rules of registering a novel therapy: The basic requirement of both FDA and EMEA from any novel therapy is that the marketing approval process should be based on safety and efficacy data coming from 2 independently-run phase III clinical trials. The need for 2 independent trials is not for one trial to cover up for “a total bust,” but to convince the regulatory agencies that the positive results obtained in one large and well-controlled study can be reproduced in a second, independent study. This requirement is routinely followed by the whole pharmaceutical industry for years, and is one of the main reasons why developing new therapies takes so many years and is so frightfully expensive.
So the interpretation is totally misguided: The development plan for DiaPep277, as described in previous press releases by Andromeda Biotech, always included 2 large, international clinical trials, and the initiation of the second trial is exactly according to the Company plans and timelines. DiaPep277 is actually well on the way to accumulating a large data set of treatment efficacy and safety, which meets pharmaceutical industry standards. Other treatments that entered later into phase III trials will have to accommodate the same rules and regulations before they can enter the market.
I researching the "two phase-III trials for approval question". If that is right, then I will rewrite this blog entry. Can you point me to a previous press release that said that two phase-III trials would be needed?
I agree that this posting is based on a misunderstanding of how new treatments are approved. I'll be removing this posting, and replacing it with another in a day or two.
I'm very sorry for my mistake.
Joshua Levy
Post a Comment