Replies to post #397631 on Anavex Life Sciences Corp (AVXL)

[Investor2014]

We can try to answer the question from a historical perspective.

The 57 week period P2a data and analysis peer reviewed paper was received for review 4 February 2020, accepted 17 February 2020 and published 17 April 2020. The study that produced the data completed November 2016. So the wait for that publication based on an n=31 study reduced to n=21 with genetic data was only about three and half years.

The PDD P2 Proof of Concept study was completed September 2020.
Over two years later, we are still waiting for the expected peer reviewed publication from that study. That study n was 132, so maybe it takes about 6 times longer than for the P2a study.

Clearly the analysis of the P2b/3 AD data isn't completed and probably won't be for several months. Then a paper must be written, submitted, accepted hopefully quickly and then peer reviewed before being published, a process that took a couple of months. The worry is that the ITT n was about 21 times larger than in the P2a study and there are many more dimensions of KEM analys, so who knows that could take at least 21 times longer than the P2a for completing analysis.

Isn't those many dimensions and larger n the apologist excuse some posters are mentioning?

The good news here is that Missling confirmed at the JPM cc that the P2b/3 peer reviewed publication is independent of the P2a/3 AD OLE study data. So we only to wait at best a couple of years on the data analysis and Missling procrastinations, so the answer could be say 3 years from now.

The most likely firsts approval is of course in Rett once the EXCELLENCE study is completed and Anavex perhaps submits a NDA based on all 3 Rett Studies in 2 to 3 years. For now we are just waiting on the amended EXCELLENCE 2022 catalyst based on the EXCELLENCE study actually completing. How long will that analysis and how many changed endpoints will that take?

Don't shoot the messenger, if anyone feels like shooting anything aim at the Anavex historical fact!. Also no retorts please with alternative facts, the ones I have outlined here is it!