Replies to post #417144 on Anavex Life Sciences Corp (AVXL)

[boi568]

The only thing that really matters now is an FDA approval, provisional or final, for AD based on an NDA for the 2b/3 trial. After that, none of the involved (and self-involved) speculations about the need for a confirmatory trial, the timing of a confirmatory trial, or the nature of a confirmatory trial, has more than minor significance.

[Steady_T]

Exactly. Obtaining AA gets the revenue stream going while running the trial. It avoids the risk of the FDA saying there weren't enough people in the trial and requiring an additional larger trial before approval.

Win win for Anavex and the FDA. The FDA avoids criticism of a too small trial n and gets to say it is working hard to meet the unmet needs of people with AD. Anavex gets the drug on the market and a revenue stream.

The biggest winner are people with AD that will now have a treatment available that offers improvement to some, stabilization to others, and a slower decline to the rest.