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Re: sab63090 post# 488894

Tuesday, 04/29/2025 4:22:32 PM

Tuesday, April 29, 2025 4:22:32 PM

Post# of 517711

for a long time I have been thinking approval with a Phase 4 confirmatory trial....he understands the normal way.



For the life of me, I don't see an substantive justification for another standalone confirmatory trial prior to approval, at least in Europe. The data is what it is over a protracted period and the safety profile is excellent. Of course, common sense may not apply and rules/procedures do often predict outcomes and with good reasons many times. If the current SOC wasn't so lacking, I might feel differently about it. I would be the first to admit there's no slam dunk here. That's why I think the outcome of the schizophenia trial is so important.
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