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flipper44

02/29/24 2:44 PM

#675291 RE: FeMike #675287

No, I’ve explained it to you. You simply don’t understand logic.

If an RFI response assessed in Phase II meets all issues raised in phase I it leaves assessment, because it is “complete,”and goes to determination. (According to the recent MHRA newsletter and link on established medicines)

If an RFI was never issued because no issues were raised by MHRA in phase I, then it is “complete” and needs no further assessment. Meaning it would go to determination.

Imo.