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Re: boi568 post# 454610

Thursday, 03/21/2024 12:54:39 AM

Thursday, March 21, 2024 12:54:39 AM

Post# of 462570
I disagree with your statement about not being able to work on the FDA and EMA submission simultaneously. While there a some difference and extra requirements for the EMA, the bulk of the submissions should be identical or very similar.

The EMA submission is not due for many months after the LOI is filed. Even if you assume the LOI was filed some time ago there should still be 4 or 5 months to prepare the MAA submission.

Hasn't Missling stated that he is waiting on the AD OLE trial to be completed?

Nunc est Bibendum

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