Anavex Life Sciences Corp (AVXL)

[Anshu2]

No company hides trial endpoint data — for peer review. Journal publications matter to professors — not companies (certainly not AD drug companies, who are shooting for billions of dollars in revenue and 10s-100s of millions through stock sale).

But, yes, I agree that CHMP/EMA has seen data that AVXL has presented to them (not sure “full”) and EMA has considered the application to be “eligible”.

However, I’m unclear (provide me a solid link, if you are clear) —- what kind of data is sufficient for eligibility. My thinking is — a “valid” P3 trial (without much assessment' of the data) is sufficient. Non-trivial data assessment is only during the review.

However, it’s also obvious to me (and EMA, IMO) that probability of approval is NON-ZERO —- so that is sufficient for eligibility. I don’t think there is anything more to eligibility.

I also believe that probability of FDA approval is zero based on current trials (simply because the current data is insufficient, and AVXL hasn’t said much for 1.5 years now).

My assessment/opinions only.