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Re: crescentmotor post# 453615

Thursday, 03/07/2024 12:49:46 AM

Thursday, March 07, 2024 12:49:46 AM

Post# of 461510
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.

The longer we wait, the sooner we will get rich!

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