Agreed. And you brought up a great point about approval. A recent rollout of the Malaria vaccine is a great example of this when the disease process causes a high enough morbidity and mortality. It had relatively unimpressive results with one subpopulation having an increased risk...and yet, is being rolled out. If a drug targets a process which has high morbidity and/or mortality without any effective treatments, it is given some slack. Further, some have stated their feelings about the B in phase 2 and its apparent shortcoming in the less intense treatment group. Just amazingly ill conceived opinion.

Consider the comparative data of B and its competitor. Tell me, if we assume that OM severity may be roughly linear within a certain range, what scenario is more plausible for inferiority? A compound effective ( from stat sign) at lower exposure but not higher or one effective at higher but not lower???? The competitor’s data gives me some concern of its effectiveness while B’s performance smacks of effectiveness with sample size anomaly in the lower exposure group. But, this is not the purpose of Ph 2 trials. So those spreading the doom manure are either simply ignorant, devious or both. Either way, I like the pattern I saw. But again, Ph 3 will bear this out