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Re: frrol post# 474784

Saturday, 11/23/2024 3:28:06 PM

Saturday, November 23, 2024 3:28:06 PM

Post# of 515649
I wouldn't say "acceptance" of the MAA has taken longer than expected (since it has not been announced as submitted), but that preparation, like for the great majority of companies in this position, has taken longer than expected.

It may be that the seven month EMA timeline underestimates what is now being expected of applicants to accomplish by the time of submittal.
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