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Re: exwannabe post# 769824

Friday, 05/30/2025 9:05:03 PM

Friday, May 30, 2025 9:05:03 PM

Post# of 823819

3) NWBO received the CHM notice that means major issues exist and NWBO must hash out with them


Maybe I'm wrong and someone will correct me, but I think the question of whether or not this is material is moot; this scenario seems extremely improbable.

1. In March the application was accepted by the MHRA

2. In June it was referred to the CHM, which from all of my digging acts very similarly to AdCom in the US - a scientific advisory board. If there were issues with, for example, trial design or the validiity of the controls used in the trial, they might stop the application right here. They didn't.

3. Instead, extensive inspections were conducted after the CHM. So yes, there may have been many issues raised by the inspections regarding quality controls and such, which would constitute many "pop quizzes" to borrow Senti's term, and the company would need to address any issues there, but if the trial passed muster on the scientific end in June and what followed were site inspections, what would come up that would send it back to CHM with a "major" scientific issue that would cause a denial/appeal?

I don't pretend to be an expert in this area so maybe I'm missing something.
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