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Re: Galzus Research post# 818124

Tuesday, 03/17/2026 3:46:31 PM

Tuesday, March 17, 2026 3:46:31 PM

Post# of 825990


If they had run a randomized trial, it wouldn't matter. You would say "gee, they did better than historical controls, but the experimental still beat the controls." And it would be a bona fide win, and it would be an approved regimen right now in the United States, not languishing in review with the British government.



I disagree. The efficacy question has been answered, in my opinion. 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if they had questions about the data would not have issued a rejection or, more likely, the application would have been withdrawn by now. Couple that with a company that is not only talking about moving to commercialization but is making multiple tangible moves in that direction points to issues other than efficacy delaying approval.
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