Replies to post #472748 on Anavex Life Sciences Corp (AVXL)

[sab63090]

Not sure about that, but surely Medicare would be happy to pay less!

Does the FDA like Medicare? hope so.

Does the EMA want to reduce their cost burden? I think so.

[frrol]

CGI was not an endpoint in our trial. Yes, placebo separation was only clear by week 48, and OLE data will be helpful.

[Doc328]

The standout info from the CTAD 2024 presentation is that, per March 2024 FDA guidance and EMA guidelines, a sole cognitive measure can serve as a primary endpoint for early AD trials (slide 13).

The patients in the trials were predominantly a mix of Stage 3 and 4. Therefore, the co-primary endpoints would be the most appropriate for review. I know others disagree with me on this staging (including you back in August!) but even Dr. Sabbagh agrees with my interpretation based on his paper a couple years ago (linked to in second link below).

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174860325

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174862742

I am still expecting that a successful larger and longer P3 will be necessary for an MAA and NDA that leads to approval. The newly released data would imply that Anavex should test the S1R WT alone in that P3 (alternatively could enroll WT and variant but place the subgroup at the top of the primary endpoint hierarchal analysis and then could do additional analysis of primary endpoint for WT+variant patients to try for the more expanded label). This type of fixed sequence analysis allows avoidance of multiplicity correction of p-values