Couldn't agree more mate. I am guiltily frustrated by how rigidly professional the ARDS trials are. Independent oversight (Institute for Transformative Clinical Trials at the Icahn School of Medicine at Mount Sinai.) under the NIH umbrella, independent stats (DSMC), designed with Fed (Bayesian powering and efficacy goals). Had MSB conducted in house RCT's like many other less professional companies it would probably have the study done by now and be out there beating its chest on results that might draw scrutiny from some quarters. In the long run we will have a indisputably tight RCT result that will literally withdraw any power of decision from the FDA - the stats decide the approval in essence.
Couldn't agree more mate. I am guiltily frustrated by how...
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