“My extrapolation of your question is why the Data and Safety Monitoring Boards (DSMBs) at the FDA has not stepped in (as you know they are typically who would or could step in and do that).”

Let’s hope that CYDY’s discussion with the FDA in regards to an interim analysis of the severe trial encourages the DSMB to review efficacy of the trial before full enrollment. My thought is that good results from the M2M trial will further encourage the DSMB to review efficacy, but remember, reviewing efficacy isn’t a mandatory task of the DSMB, it’s only when deemed appropriate. I think this is an appropriate case, but it’s hard to interpret what the FDA thinks.