Thursday, February 29, 2024 5:14:29 PM
I asked them if they could confirm that their designated “Phase 1” and “Phase 2” of the 150 day assessment guidance document would both occur regardless of the need for an RFI, or if Phase 2 could be bypassed if no RFI was sought by MHRA.
I also asked them to supply me with further literature that I could study regarding the MAA assessment process, with specific interest in the facets of Phase 1 and Phase 2, if they could not definitively answer my question.
Again. I have almost zero confidence they will respond to this request as they state they do not reply to request for information.
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