Replies to post #414933 on Anavex Life Sciences Corp (AVXL)

[Hoskuld]

Correct. No one would characterize getting ready to run another P3 as "moving to commercialization". Only a P4 would meet that criteria.

[Joseph_K]

I don't believe a P3 confirmatory trial allows the company to commercialize their product while the trial is going on.

I guess I'm confused. Isn't what you describe precisely the Leqembi situation? I thought Biogen got approval to sell the product, based on surrogate biomarkers under Accelerated Approval, while they still didn't have the Phase 3 all wrapped up, and that the approval could be revoked if the FDA turns out to be not satisfied once the whole Phase 3 package is submitted and assessed.