Anavex Life Sciences Corp (AVXL)

[Investor2014]

Whether the company was within the rules will imo depend on whether the trial is deemed a P2b or P3 pivotal registration trial.

This sound like a conundrum in itself. But if it turns out to be deemed a P3 registration trial by the FDA for traditional approval, then of course I and some others will be proven delightfully wrong. And I mean delightfully both from my own perspective and for others to glee over.

On the other hand if a P2b with or without AA potential with surrogate endpoint biomarker(s), then the endpoint judgement criteria falls more to the wayside as a lesser issue. I and a few others will the been proven correct that it was not a pivotal P3 meeting all endpoints for traditional approval.

If we then in fact achieved AA I will also be delighted.

If no AA and Anavex designs and initiated a P3 Precision Medicine trial that enrolls for responders to A2-73 only and that introduces a titration scheme based on everything learned, then things are taking a completely expected course and Anavex will need to review their investor communications approach.