Orexigen Starts Partnership Talks On Obesity Drug Contrave
This article was originally published in The Pink Sheet Daily
Executive Summary
Firm stresses Phase III efficacy results will pass muster with FDA.
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Orexigen Insists Revised Contrave Data Should Not Affect Timing Of NDA
FDA tells the biotech corrections to secondary endpoint data for one pivotal study for its diet pill filing comprise only a clinical amendment.
Orexigen Insists Revised Contrave Data Should Not Affect Timing Of NDA
FDA tells the biotech corrections to secondary endpoint data for one pivotal study for its diet pill filing comprise only a clinical amendment.
Orexigen Insists Revised Contrave Data Should Not Affect Review Timeline
Although Orexigen Therapeutics needed to correct data included in the NDA for its Contrave obesity drug, the company appears to have weathered some shareholder concern and may be on an unchanged timeline for FDA consideration and approval of its application