Replies to post #414426 on Anavex Life Sciences Corp (AVXL)

[Hoskuld]

I think the main reason the FDA typically requires 2 P3 trials is that the 2nd one confirms findings found in the first. So, much as I want to interpret "confirmatory" as meaning P4, I would want to hear that definitively before assuming as much.

OTOH, they did say they have begun the process of seeking approval on the basis of the recently concluded P3 and were they to receive it then the confirmatory trial would indeed be a P4.

IMO the PR leaves plenty of wiggle room for competing interpretations.

[Investor2014]

Reading and Comprehension are good skills to have when investing in biotech too.

P3s are to demonstrate whether or not a product offers a treatment benefit. That is NOT confirmatory.

What then is one or more P3 trials, if not confirmatory of P2 findings and each other?