Thursday, January 02, 2025 11:57:33 AM
Realty is that the ORBIS review is ALWAYS run by the FDA, based on an FDA BLA/NDA and on the FDA based calendar. Once the technical review is complete the various RAs that elected to sit it on the review can do what they want.
Sure, the program s to allow many to approve at the same time. The reality as everybody in the space knows is it intended to assist the smaller RAs in keeping up and not being years behind the majors in getting approval.
But guess LP knows best. MHRA really is the fastest agency out there. LMAO.
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