Replies to post #453615 on Anavex Life Sciences Corp (AVXL)

[boi568]

The 85 percent approval stat applies upon submission. Ten percent of applications are subsequently withdrawn (clock stop problems would seem to fit) and the other five percent are ultimately rejected by the EMA.

[Investor2014]

Clock-stop 1 is where most feedback and requests from CHMP is submitted to the company. Clock-stop 2 may or may not be needed.

A final positive opinion from the CHMP is then submitted for EMA at EU level in case of central procedure recommending approval.

Depends how you define accepted, but I understand it as post the EMA process Day-1 validation of the applicant’s MAA submission for review.

It requires an accepted MAA to moved forward from there. I want to see Anavex move past Day-1 before having a view on chances of approval.