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AMAG’s Explanation For Makena's Failed Confirmatory Trial Faces Skeptical US FDA

Executive Summary

Post hoc analyses show no convincing evidence that PROLONG trial's failure to meet its coprimary efficacy endpoints stemmed from baseline risk differences in subjects compared to an earlier trial, agency says; advisory committee is being asked whether to withdraw accelerated approval or keep the drug on the market, with or without a new confirmatory study.

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