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Re: sab63090 post# 388261

Saturday, 12/03/2022 10:39:14 AM

Saturday, December 03, 2022 10:39:14 AM

Post# of 458433
Given the dose response seen in prior work (50mg always more effective), the significant combined data presented is likely due to very strong results in 50mg group (highly significant) and weaker results in the 30mg group (may be close but not quite significant). It would have been easy to break it out that way. I have to wonder whether they chose to present the combined groups (any exposure to the drug) because it bumps up their intervention sample to over n=300, which would be more convincing as a P3-size trial sample. With all of the highly critical comments posted over the past 24 hours I think there is a "missing the forest for the tress" issue - you don't get results like they reported if there is not a real signal. The minimal data presented so far may be confusing without adequate context and explanation, and there may be errors in specific numbers, but the bottom line is the drug clearly works. If they can show that 50mg works better than 30mg and that achieved drug levels correlate with efficacy (and other findings getting at the idea that the hypothesized MOA is correct), I think the drug has a shot at approval but maybe with a P4 follow-up.
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