Makena Hearing: Covis Seeks To Skip Question, Likely Negative Vote On Confirmatory Trial Results
Executive Summary
By proposing to stipulate that findings from the PROLONG study do not verify Makena’s clinical benefit on neonatal morbidity and mortality from complications of preterm birth, Covis could avoid what would likely be a highly negative vote on the first question posed to the advisory committee at the 17-19 October public hearing on withdrawal of the application.
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