The problem here is that the SoC, a laxative detested by patents and hospital staff, actually world fairly well, so showing an incremental statsig improvement by adding OCR-002 may be tough.
I missed this prior point of yours about SoC being pretty effective on its own so I'll dial back some of my prior concerns on the interim look showing the need to increase the trial size. Just curious, why is the SoC so detested?