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Re: boi568 post# 391065

Friday, 12/09/2022 11:45:43 AM

Friday, December 09, 2022 11:45:43 AM

Post# of 461197
Well, if I was an FDA decision maker and saw that 10-15% of the population improved -4 from baseline after 48 weeks when most patients deteriorate +4, I would be inclined to approve just based on this and the safety profile even if the 85-90% "other" patients did not show much of a mean difference, as long as they were not getting worse than placebo, which I am sure they are not. This is life changing for 600,000 to 1 million Americans. Now if you can find a biomarker for this population, then the FDA would have to approve, there would be zero reason not too. With 10-15% super responders and a biomarker = 100% approval chance as long as safety is good. 10-15% super responder without a biomarker, I give 80% chance on this alone.
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