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Makena Hearing: Covis Seeks To Skip Question, Likely Negative Vote On Confirmatory Trial Results

 
• By Sue Sutter

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.

Fast forward
Covis wants to skip the first question on whether the PROLONG trial results verified Makena's clinical benefit. • Source: Shutterstock

Covis Pharma is requesting that a discussion and voting question related to the PROLONG confirmatory trial be eliminated from the October public hearing on potential withdrawal of Makena’s (hydroxyprogesterone caproate, or 17-0HPC) accelerated approval.

For Covis, getting this question eliminated from advisory committee consideration at the public hearing could head off what likely would be an overwhelmingly negative vote on the first question...

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