Anavex Life Sciences Corp (AVXL)

[Joseph_K]

12x, your post raises some questions for me. (That's a good thing. :) )

3. ... I would assume Anavex asked for analysis done for both p2b and p3 standards. And decided success based on p2b criteria.

In its P2b/3 trial, Anavex could have had two different sets of endpoints? (The entries in clinicaltrials.gov don't read that way. Additionally, the purpose of Phase 2 includes showing efficacy, which is what's at issue in whether the trial was a success.) (Different issue, but it strikes me as a securities-law violation if Anavex believed the trial was a success only by "P2b criteria" but announced all endpoints were met.)

4. It doesn’t seem the pre-specified gene[t]ic analysis made a difference. It’s material info the company is required to disclose…Otherwise the company would have announced it by now as tradition p3 success with pro-specified subgroup instead announcing a p2b success with AA.

I don't read the 10-Q that way. I read it that the wild-type Sigma1 variant made a big difference in the AD trial, based on this:

We believe that excluding patients with SIGMAR1 identified biomarker variant (approximately 10%-20% of the population) in prospective studies would identify approximately 80%-90% patients that would display clinically significant improved functional and cognitive scores. The consistency between the identified DNA and RNA data related to ANAVEX®2-73, which are considered independent of Alzheimer’s disease pathology, as well as multiple endpoints and time-points, provides support for the potential precision medicine clinical development of ANAVEX®2-73 by using genetic biomarkers identified within the trial population itself to target patients who are most likely to respond to ANAVEX®2-73 treatment. We may in the future utilize such an approach in Alzheimer’s disease as well as indications like Parkinson’s disease dementia or Rett syndrome in which ANAVEX®2-73 is currently being studied.