Anavex Life Sciences Corp (AVXL)

[Investor2014]

I guess something like that, but more specific though - looking for ways to navigate points like those I list below.

The figures don't lie but liars can figure

-Tolerability / titration meant no high and medium dose arms - conflated into one. No clear dose response separation showing clear drug effect - don't Boi's no-linear distribution theory will help, maybe the totally of results will?
-One co-primary endpoint failed - made up for by multiplicity rule - will that all look on deep inspection as it should to CHMP?
-Will the delayed start OLE really make up for a confirmatory trial?
-MRI brain region analysis and results do not appear to include the key regions normally looked for - although much looks impressive in the company's presentation - how much weight will it carry?
-More I am sure that CHMP will have drilled into...

The methodologies used to navigate the trial outcomes differing to protocol in a relative small and short AD trial is to me the big questions, which I am pretty sure is what the CHMP is keen to go deep investigating and asking questions about. Will the concerns be outweighed by the methodologies used to extract a trusted results?

True that those key limitations would have been known to EMA/CHMP at MAA acceptance time. Now we wait to see what the deep dive has brought out and importantly if Anavex is providing convincing replies.