Anavex Life Sciences Corp (AVXL)

[Investor2014]

Here is an example from today of a company initiating a confirmatory P3b/4 trial to support post-marketing regulatory requirements for an accelerated approval pathway.

CymaBay Initiates AFFIRM, a Phase 3b/4 Study Evaluating the Effect of Seladelpar on Clinical Outcomes in Patients with Cirrhosis due to Primary Biliary Cholangitis

Note that the company hasn't yet achieved AA, but if they do it appears the plan is to convert the initiated confirmatory trial to a P4 and if not to continue as a regular P3 trial aimed at traditional approval.

Has none of our resident Biotech WGT experts still not found an example of just replacing the requirement for a confirmatory study with OLE data?

I wish Anavex would list the presumably numerous occasions when OLE data, like they heard from this KOL dude, was accepted in place of a confirmatory trial for an AA pathway. Maybe then $AVXL would once again gloriously be a $7 stock!!!