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Re: NotSure2 post# 659676

Thursday, 12/28/2023 10:24:52 AM

Thursday, December 28, 2023 10:24:52 AM

Post# of 822893

Exactly, July-Oct 2024 timeframe for approval more likely (clock stop extension could be requested, an additional 60 days)

That is correct however an extension for the clock stop period of 60 days is rarely provided by the MHRA.

Requests for extension of the clock off period for up to another 60 days may be granted only for exceptions

https://www.gov.uk/guidance/guidance-on-150-day-assessment-for-national-applications-for-medicines

And because we all know that NWBO is not the fastest in the group and encountered many delays over the years... I so hope NWBO does not need an extension and will not be caught off guard when they have to meet the 60-day clock stop deadline (if an RFI is pulled by the MHRA)
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