Third, at a key FDA EUA Antiviral Advisory Committee meeting, Merck did not present any exploratory analyses or other rationale for why the interim analysis showed a 50% reduction in hospitalization for molnupiravir, but then the second half of the study showed a trend favoring placebo and no difference in mortality (one event per group). 6 Bias associated with interim analyses has been widely studied. 7 A reversal of the treatment effects after an interim analyses seems unprecedented.
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