CDER Opposes Covis’ Bid To Steer Focus Away From Makena's Failed Confirmatory Trial
Executive Summary
The company offered to stipulate that findings from the PROLONG trial do not verify clinical benefit of the preterm birth prevention drug; the US FDA’s drugs center opposed a stipulation, saying failure of a confirmatory trial to verify clinical benefit is an independent ground for withdrawing accelerated approval and an advisory committee should vote on the question.
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