I agree. I think the FDA sacrifices lives sometimes to get the best data to prove efficacy. Patients that are sick enough to file emergency IND should be put in randomized trial. The outcome is live or die. No physician's biased opinion will change that outcome. We have a fairly good idea of what the outcome on placebo will be. How many of these trials are on using placebo? Why does each trial need one? We have enough data to estimate what the outcome of placebo would be. Do we have to do one in each trial.... seems maddening.

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In addition, the FDA suggested the Company file a second randomized protocol for all COVID-19 patients in severe condition, so as to preclude each physician from filing an emergency IND for every patient to be treated with leronlimab.

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