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Re: flipper44 post# 661203

Wednesday, 01/03/2024 5:22:49 PM

Wednesday, January 03, 2024 5:22:49 PM

Post# of 726500

2. Starts the 150 day or 210 day clock. It does not start without it.

Its either 80 days or 210 days after acceptance not 150 or 210. If after 80 days the MHRA does not have any questions then there is no need to have the 60-day clock stop RFI and thereafter the 70 days to study the answers the biotech provided and decide on approval. The MHRA can then decide after 80 days to approve
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