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Re: flipper44 post# 805931

Wednesday, 12/31/2025 8:44:13 PM

Wednesday, December 31, 2025 8:44:13 PM

Post# of 820045
According to your AI analysis, I am correct and we agree on the following:

1. There are no remaining major objections or deficiencies. As a result, no 28-day CHM letter is required or needed.

2. This fact is further supported by the actions of Linda Powers moving forward with the construction of the simplified Class C suites at the Sawston facility.

3. “If the CHM provides a Positive Opinion with conditions for 28 day response, the MHRA doesn't issue a "CHM Letter" (which is reserved for objections). Instead, they move directly to the Grant Procedure”’.


Let me know if you disagree with any of these 3 points.

Also, please provide a non-AI / actual MHRA guidance link showing that if the CHM provides a positive opinion, they will give the Sponsor 28-days to meet the minor conditions.

I do agree that if the CHM committee provides a positive opinion, then the MHRA may issue a Grant (Approval) decision letter with minor conditions, but it does not come with a 28-day letter response requirement.

But, if you have a link to this requirement, please provide it.
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