Replies to post #391293 on Anavex Life Sciences Corp (AVXL)

[plexrec]

"If the endpoints are all hit with the 50mg arm and there are dozens"--why wasn't this info available at time of Ctad Presentation ???? Why present when your data is incomplete ??? Not bash'n just say'n !!!! Long Avxl !

[Anshu2]

No, FDA is not that simple. FDA review will look at numerous things and raise many questions. Ones I can imagine are related to: dropouts, titration, no dose response (if 30mg shows no benefit) and this a small trial (160 in treatment), etc. FDA will have many more questions that we can’t even think of.

You should read a public briefing docs — which is typically 100-300 pages long, and you’ll see the extreme extent to which FDA analyzes/scrutinizes.

I have been very very impressed by FDA for that reason. They deserve all the praise (even though they are NOT flawlessly competent).