that was a fantastic posting and video to watch. The point you made was clearly made as also was the point, that it is very rare, to have an RCT NIH trial stopped early, other than for futility.
This was also commented on previously, by another poster. IMO, make no mistake, if the trial is stopped early due to efficacious reasons (statistical , ethical, observable) t's a treatment worthy of a cape and undies worn on the outside. The SP will reflect that!!
However, the reality of the trial going the distance does not detract one bit from its potential (to treat nor SP). This is the norm not the anomaly.
I would also, like to add, the stats rep at ODAC spoke of numbers in MSB trials and unease in sample sizes and i think was the one who changed her vote by hitting wrong button despite being split 51/49? By potentially going the distance in an RCT that is double blind with a sample size and methodology agreed upon and set by NIH in consultation with MSB, with favourable results, it will put to rest two of major concerns (objectively), raised at ODAC (despite a 9:1 vote) and seemingly clear the way.
If we were surprised at FDA CRL post ODAC, can't imagine the reaction of MSB peers within the medical and scientific community and shareholders if lightning struck twice.
Father time needs to do his thing. On the covid ARDS trial anyway.
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