Orexigen On Quicker-Than-Expected Pace To Obtain Data Needed To Re-File NDA For Contrave
This article was originally published in The Pink Sheet Daily
Executive Summary
During its second quarter earnings call, the biotech said it sees recent FDA approvals of two other obesity drugs as a positive for its own prospects, but it is re-engaging with the agency on why it must perform a cardiovascular-outcomes trial prior to approval.
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The company is optimistic it can work out an agreement with FDA to re-file the obesity drug application before it has interim data from a cardiovascular outcomes trial in hand.
Orexigen Eyes Earlier Resubmission Of Contrave NDA
The company is optimistic it can work out an agreement with FDA to re-file the obesity drug application before it has interim data from a cardiovascular outcomes trial in hand.
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