@Denial Suspect 2x2 was always there as a fallback. I seem to recall the company saying that FDA asked them to do the non-clinical adrenal studies concurrent with the trial (implication being it would support reversion to 2x2 if required maybe?). I would think 2x1.5 would have had some effect (eg. original Ghosh study was 1x3 for 4 weeks) but agree the commentary around those results has been ambiguous, confusing and inconsistent. But if we were gunning for the 2x2 lookthrough all along, it makes more sense to dismiss the 2x1.5 out of hand. I think we were railroaded into 2x1.5 rather than choosing it becuase we thought it was optimal (note - we only went that way after feedback from FDA). If anything, perhaps we set the 2x1.5 threshold as a stretch target, so that we now have reason to revert to 2x2 with 100s of data points and statistical significance with n of 20. Who knows!
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