Replies to post #502154 on Anavex Life Sciences Corp (AVXL)

[Investor2014]

Doubtless first of all we are all hoping that the CHMP are swayed by the OLE and post hoc data analysis.

That Anavex decided to spend 2 years before filing the MAA and another year after not starting that confirmatory trial hopefully won’t prove unforgivable.

If an EMA approval becomes reality, that confirmatory trial will imo still be required and if so conditional approvals elsewhere could be in the cards.

[boi568]

We aren't discussing research guidelines; they are decisional guidelines. The research underlying the current decisional guidelines is outdated, which is why the draft was [past tense] progressing.

As time has gone on this year, Anavex has produced more and more persuasive evidence that could support an FDA approval, assuming an NDA, despite the old guidelines. There appears to be a lot of ammunition now for the Agency to justify an exception.

What are the odds of the ABCLEAR3 results to be just a random outcome that must be guarded against? Let's analyze that. How many unrelated lightning strikes will it equal?