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Re: Investor2014 post# 488944

Wednesday, 04/30/2025 12:39:04 PM

Wednesday, April 30, 2025 12:39:04 PM

Post# of 517756
There are plenty of details for the rapporteurs to attend to besides whether they should have allowed a single trial MAA to be submitted in the first place.

You really have it backwards on regulatory standards, which lay upon the applicant and not the agency. And if there are no regulatory standards set forth by the agency in some regard, it will not magically appear during review.
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