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Sunday, 10/24/2021 7:11:43 PM

Sunday, October 24, 2021 7:11:43 PM

Post# of 43139
Hoping I can have some others chime in for a post I replied to on SW. Info is from MHRA guidance on expedited rolling reviews.

According to our PR Oct 1st we've submitted all planned modules, which corresponds to the validation of assessments (MAAs) portion of the rolling review. According to the process final phase assessment, which we are in currently, "should" take 100 days. This is done in a 60+40 day phases. They can issue a letter for information (RFI) by Day 60 (Nov 30 for us). Then the "clock" is stopped for up to 30 days until response from HGEN. After RFI is returned MHRA has 40 days to make a decision.

Therefore, without an RFI decision by UK will be given to us by Jan 9 2022 (best case scenario). With an RFI that puts us at Feb 8 2022. My bets are sometime in January 2022.
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