Replies to post #473027 on Anavex Life Sciences Corp (AVXL)

[frrol]

The company has delayed the FDA filing, but not the EMA filing. And rightly so: well before decision time, the EMA will have finalized its AD endpoint guidelines. 

Our FDA delay is very likely to focus on the EMA, and then leverage that effort into the similar FDA submission. Could have been done simultaneously, but the company seems to want to take a more conservative approach. May have been partly due to resource constraints.

[sab63090]

Seems like Dr, Jin knew this change at the FDA was coming & I think Sokol is spot on...maybe the OLE is the ticket. I did understand Investor's point of view, but things change in life and people need to adapt to new thinking especially when the cost of Medicare coverage costs so much

[Hosai]

"Why hasn’t the company acknowledged a trial failure per the agreed SAP and initiated a targeted Phase 3? The likely explanation is their awareness—perhaps through Dr. Kun—of the pending FDA “sole endpoint” guideline, so they opted to await its finalization."

Dr Jin argued in the Sept 2023 pr that because both co primary ADAS COG and secondary CDR SB were both under p value 0.025 the trial was successful so it wouldn't appear to be a case of waiting for sole endpoint. EMA process initiation was PR'ed a few months later.