Replies to post #173493 on Anavex Life Sciences Corp (AVXL)

[Investor2014]

Wouldn’t a Basket trial evaluating A2-73 against several CNS diseases in single trial be the most appropriate over a Master protocol evaluating several different drugs in the same indication?

Although it seems to me a major exercise in recruiting and organising such a trial.

[nidan7500]

FDA s WOODCOCK: “ The clinical trial system is broken “

Roger that CK...we spotted that a while ago.

IMO, the FDA has the best process docs and tech writers on the planet. Docs are well written and well kept, that is an excellent process IMO. In fact many of them are the LAW. But when a regulatory body admits for AD they cannot measure effectiveness or criteria for treatment after 20+ years of trying. And AD stage 1,2 for up to the first 2+ years of the trail cannot be functionally measured and that following that all they have is dubious cognition trial criteria, you know they are in trouble. This on a CNS disease which no one has ever walked away from and it is in the top 10 deadliest on the planet. They then allow statistical rationale (by BIIB) to be applied for trial acceptance after admitting the cognition measurement is clinically weak.

AND-Not clear how any positive CNS disease results for the AVXL portfolio can be managed by FDA and other regulatory bodies WW considering the human need. We'll see soon enough I hope. Lets see how they splain that one.