RE: Home Trial9 Apr 2021 15:27
Right. But for that assumption to work, the have to stratify patients in way that actually fits that calculation and obviously the smaller the trial the bettet the chance for bad luck as well as good luck, so there is usually a buffer of extra patients anyway. But my main issue is how RM is communicated this in the interview, which was once again really poor and let's not fool ourselves, he did give very clear hints that they did not get as many events as they would have liked. It is also clear to me from the clinical trial records that they added the 60/90 days readouts after unblinding per original protocol.
But again, it isn't so much the trial that bothers me as how RM is handling it changed the tone all of a sudden from at risk to patients with oxygen instead of explaining what happened and how they plan to approach it. For example, in the activ 2 trial they are looking at biomarkers, so even of the signal is smaller, it can still be high confidence if the biomarker data fits the hypothesis.
Not to mention that he, correctly, said that the virus needs to be there and relicating, before changing the tone to patients in oxygen, except the virus is very much replicating early. A complete trainwreck.