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Re: Doc328 post# 445631

Wednesday, 01/03/2024 1:14:49 PM

Wednesday, January 03, 2024 1:14:49 PM

Post# of 517275

"I do not think Anavex will apply in June, or even at all without an additional trial."


The company didn't approach the EMA just for giggles, obviously. They intend to "apply", ie submit an MAA, in around June. Nothing foreseeable will stop that. You'd have to explain why the company possibly would not. (Note: There are optional pre-submission meetings with the CHMP, but they are merely to ensure the MAA is prepared correctly, not to pre-evaluate it.)
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