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exwannabe

03/17/26 4:01 PM

#818220 RE: froggmister #818213

It makes no sense that the regulatory agency that has known the trial data for more than two years and got it through their CHM in June of 2024, if they had questions about the data would not have issued a rejection or, more likely, the application would have been withdrawn by now.


I guess you fail to understand that by law the MHRA cannot just issue a rejection.

After the complete review, that allows for the sponsor to respond, if they still have major objections they must then send that to the CHM for advice. If the CHM is going to agree with the MHRA, they must let the sponsor know and the sponsor has a chance to present their side. They are allowed 1 month to say they want to present their side, then 6 (or more) months to present it.

But why should MHRA abide by the law?