They used the word “appears” because the p val
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Quote:
They used the word “appears” because the p value is not less than 0.05, and they didn’t want to upset the FDA, but I think Ohm is right, that a larger mouse study would probably bring that p value to less than 0.05.
A larger study would drop Resmetirom below .05. But I was referring to leronlimab dropping even further. With our phase 2 already done and supporting evidence for mechanism of action and dosage from this study we are set to go directly to a phase 3 trial. The caveat is that the FDA would probably require a dose escalation as part of the trial. If the trial is for early stage MASH than it would be leronlimab vs. standard of care (Resmetirom). If it was later stage than it would be leronlimab vs. placebo because Resmetirom is not approved for later stages. In either case with a properly sized trial a a p value for leronlimab of .005 or better wouldn't surprise me.