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With SPA Finalized, Orexigen To Begin CV Outcomes Study For Contrave In Second Quarter

This article was originally published in The Pink Sheet Daily

Executive Summary

The company expects to be able to re-file the NDA for its obesity candidate by 2014, after 87 major adverse events were recorded in the 10,000-patient, placebo-controlled safety trial.

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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.

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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