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Saturday, 03/06/2021 7:52:04 PM

Saturday, March 06, 2021 7:52:04 PM

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Let's say you flipped a coin once a day for 365 days. You might have a good outcome on Mondays. Let's say you had 32 heads and 20 tails on Mondays. You could say that there is statistical significance on the Monday portion of the trial. Obviously, it is only random chance and one day of the week is going to a 32/20 split through sheer luck. That is like this trial. When you slice and dice a study, having 62 patients in one subgroup have a 24% advantage in a category means little to nothing to the FDA. The same as the NEWS2 results in the M2M trial. The FDA knows it could be random. There is a 0% chance of an EUA at this juncture. Maybe the study will be continued with only critical patients. Maybe a study of 1,000 patients. If the results are replicated, then an EUA is possible. A trial needs to meet its primary endpoint for the FDA to believe it is real and not random.
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