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FeMike

01/26/24 11:39 AM

#667344 RE: dennisdave #667342

Not exactly, there are multiple conflicting statements from MHRA that say it is within 150 days of submission and other sections that say the 150 days start upon validation.

I had found a document/statement/guidance, I cannot remember, that specifically addressed that the 150 (or 80 day, it may have been referring to Phase 1) clock was backdated to start on the date of submission if the application is ultimately validated.

It was very unique in how it addressed it. I've been looking around and cannot find the damn thing though. Frustrating.