I’m guessing 90% here did not know that inspections are not typically conducted in Phase I (80 days) of 150 day accelerated review. When conducted, they are conducted the last 70 days of the total 150 days.
Hey Flip
Sounds an awful lot like Phase 2 is necessary even if there isn't an RFI.
But still back in Jan you were touting SWIFT approval and very fast approval because MHRA has said and funded faster approvals . So did they change inspection stuff since then or you changed your mind now as MHRA hasn’t delivered on any such fast progress so far