Ann: iPPS Demonstrates Multiple DMOAD Signals in Phase 2 Study, page-195

.....so the chance that a study with 500 participants in each arm achieves statistical significance is extremely high.

the results we got with close to p<0.05 on such a small sample size are unlikely to be a lucky random result, so a larger has an extremely high chance of achieving statistical significance (if we do so).

However I, like others, think we should push ahead with the trial for pain, function, etc and not go for DMOAD if we need to delay timelines again and cost significantly more until we have already launched the drug in its non-DMOAD label form. Even if we just modify the P3, it will cost alot more and take alot more time to process. If they go the direction of trying to expand the label at the cost of material delays in final approval, it really shows a very poor understanding of capital allocation. They need a proper cfo.