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ATLnsider

12/31/25 9:49 PM

#806049 RE: flipper44 #806047

flipper44, I believe your AI source is confused and is also conflating two different and separate scenarios.

The source it stated for the 28-day statutory source was found in The Human Medicine Regulations 2012, Schedule 11, Part 1, Paragraph 6.

However, this section of the regulations is for instances when the CHM decision is negative, and the MAA is refused or denied by the MHRA. This provision gives the Sponsor / Applicant 28-days to file a response or an appeal.

This provision is not relevant when there is a favorable CHM committee decision, and the CHM is recommending that the MHRA approves the MAA:

Bullish
Bullish