Anavex Life Sciences Corp (AVXL)

[RedShoulder]

You absolutely cannot compare patient populations for the Biogen studies, whether Aduhelm or for Lecanemab, with ours. They knew they needed those large numbers to differentiate minute improvement over placebo (22% and 27%, respectively) to reach statistical significance. In fact, in a prior 854 patient trial they FAILED to meet the primary endpoint. They needed numbers. It was the same story with Adu…address failure through trial design (in this case many more people and longer duration).

Based on our phase 2a and PDD OLE studies we determined 500 would be more than enough to demonstrate clear stat sig and stout effect size. If we can get anywhere close to replicating that much smaller phase 2a that showed improvements from baseline, this is a game changer and 500+ plenty.

Point on target Veliger. If the AD TLD readout is as good or better than the Ph-2, and I think it will be based on trial design from the Ph-2 data, I'm looking for FDA to give Anavex an AA , Accelerated Approval, and a P-4 follow up.

If the data is very good, another P-3 will not add any new information. There will be pressure for FDA approval from Alzheimer support groups if the data shows that some did not decline and some improved, as shown in the Ph-2 trial. Which will crush the Biogen results that had adverse events and only slowed the decline a bit.