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Re: exwannabe post# 769824

Friday, 05/30/2025 2:25:51 PM

Friday, May 30, 2025 2:25:51 PM

Post# of 824113
I agree with your assessment and timelines. However, the CHM letter is usually a precursor to denial, pending appeal? Someone here suggested that scenario. If that were the case, it would be a material event, do you agree?

"A CHM letter from the MHRA (Medicines and Healthcare products Regulatory Agency) in the UK is a formal notification that the Commission on Human Medicines (CHM) is advising against approval of a marketing authorization application for a medicine, potentially leading to denial. While not a direct denial, it signals a strong likelihood of refusal. "
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