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exwannabe

06/19/25 12:31 PM

#772194 RE: attilathehunt #772190

Someone should ask the company a hypothetical question.... If the MHRA denied the approval and referred the decision to the CHM, would the denial from the MHRA require the company to issue a FD PR?


You need to ask the correct question.

"If the MHRA had major objections that would prevent approval and referred to CHM for resolution before making a final decision, would NWBO disclose this".

The key is if MHRA has actually made a decision. Per the law, the actual MHRA decision is after the CHM has had a chance to opine.
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manibiotech

06/19/25 4:07 PM

#772214 RE: attilathehunt #772190

Referring to CHM is not official rejection by MHRA. They will wait for CHM recommendations , if that was actually the case . These are all hypotheticals as no one knows what the current status of MAA is .