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Re: FeMike post# 764806

Tuesday, 04/29/2025 1:47:54 PM

Tuesday, April 29, 2025 1:47:54 PM

Post# of 774744
Thank you Femike great DD.

Also, I just realized, it may not have been in direct response to me but the question that sparked Julian Beach's response on 'major objections/CHM meetings' I had sent in an inquiry about to the MHRA in February. Almost verbatim, but I referenced the date of January 1 2024, not September 2024 and asked whether the MHRA are prioritizing application submitted after the guidance changes in order to meet metrics for "all applications submitted after January 1 2024".

Today, one of my contacts told me that last time two weeks ago he spoke with Les they had not received any MHRA objections.

I remain with my assessment, which is that at the end of last March, they received a new RFI following the data inspections at the medical trial sites, and that clock-off period is what we are in now.
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