Replies to post #137206 on Anavex Life Sciences Corp (AVXL)

[polarbear77]

So should we place more faith in your “guesswork” than in the CEO’s actual words just 1 month ago on 12/11/17?

Are you more informed than he? Pray tell.

“Last month at CTAD, Anavex presented pharmacokinetic and pharmacodynamic data from our Phase 2a clinical trial and Phase 2a extension trial with ANAVEX 2-73 in Alzheimer’s Disease, as well as ongoing favorable safety data. We are advancing ANAVEX 2-73 into a Phase 2/3 study in Alzheimer’s disease.
Extensive analysis of Phase 2a data, including the integration of genome sequencing information from the patients treated with ANAVEX 2-73 has been performed in order to understand the trial parameters, which should help to increase the odds of late stage trial success.

We are currently in the process of making the necessary regulatory submissions for the Phase 2/3 trial, which we expect will be completed within the upcoming quarter.”

[XenaLives]

The fact that other drugs with a totally different MOA have failed will have no influence on FDA requirements for 2-73. The suggestion is absurd.

[nidan7500]

https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UCM592001.pdf...

Check out pg 13. The new rules are written to allow discretionary authority to FDA when interim trial results warrant such. Very cool. IMO.

Completely agree - with so many AD drugs failing FDA will not take risk of approving anything on limited data/results. They will definitely ask at least one P3 - so co as well may do a very good P2b

In any case we are looking at 2-3-4 year journey