Don't disagree Kervio, and hello. Long time indeed.
Not just one trial. Four! Its such a shame. All the evidence hints to the science working, but they never sufficiently empirically proved it to the satisfaction of regulators or otherwise. Had any one of the trials been designed/conducted a little differently, they would be in a very different place - the poor choice of primary endpoint in chronic heart my only real issue with the company, the others down to factors beyond their control.
You are very able on the empirical design side. I cannot help but think their hands were tied in the NIH directed C-19 ARDS trial, but do think the DSMB should have changed the parameters of the trial. When the principle standard of care drastically changes in your control cohort during the trial on a little understood virus, surely the trial parameters need to be change? That's one of the few circumstances where its generally deemed acceptable to change trials once commenced.
Your thoughts?
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