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Re: Joseph_K post# 453620

Thursday, 03/07/2024 2:01:13 AM

Thursday, March 07, 2024 2:01:13 AM

Post# of 463919
I think the EMA will not be making announcements short of a final approval/ disapproval decision. Why should they?

And I don't see anything like Investor's supposed critical EMA submission acceptance step. Anyone who has submitted forms to a regulatory agency (or a court, for that matter) understands that required forms are accepted after a brief review for completeness and fee paid. This is not a substantive moment in the administrative process.

In this case, for example, the EMA is not going through a professional evaluation of the merits of an, e.g., 100,000+ page package on the day it is brought before them. That's what the subsequent 12 months or more review time is for. In some format the MAA will be time stamped as received and accepted -- starting the clock -- and then the Agency's real work will begin.
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