Replies to post #465203 on Anavex Life Sciences Corp (AVXL)

[Kb1123]

And there it is!!

[12x]

Here are the full AAIC presentation slides: https://www.anavex.com/_files/ugd/79bcf7_79c4b8754b9f4eaca6da3e912e11689b.pdf
There is only 108 out of 154 in the 30mg and 83 out of 144 in the 50mg cohort finished the trial, or used in the endpoint calculation. n changed.

[BAR123]

I will take the advice from renowned Dr. Marwan Noel Sabbagh, MD, Professor of Neurology at Barrow Neurological Institute and Chairman of the Scientific Advisory Board than a pretend doctor on an internet chat board.

[Investor2014]

Yes the dropout rate in the first 24 weeks was huge in both drug arms, about 1/3.

Likely the results given are for completers only and if so pretty much invalidates approval chances. Although the plasma biomarker correlations look good.

The absolute reduction in brain atrophy is tiny and unlikely to have weighed much on clinical outcomes. MRI accuracy / sensitivity likely too low making those reduction figures unreliable.

Note also that we now know that eligible for the OLE was about 70% (including placebo).

I’ll stick with my less than 50% EMA approval and agree with your almost none for FDA approval given the near complete lack of ethnic diversity.

[sokol]

“Anavex still playing games…”. Is Dr. Marwan Noel Sabbagh playing games as well?

[ExtremelyBullishZig]

If they don't apply...there will legally be a huge issue. Specifically calling out that they will be filing by a specific date is a huge call for investment. It isn't just a date that a trial may end...it is telling the world that they have a drug that should be approved. Lawsuits will be real this time if filing doesn't happen.