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News Breaks | | | | January 7, 2013 | | 08:32 EDT |  | OREX | Orexigen announces progress with FDA with resubmission of Contrave NDA
Orexigen Therapeutics announced progress with the FDA on a faster path to resubmission of the Contrave New Drug Application. Consistent with the spirit of the formal dispute resolution request response letter issued to the company in October by the FDA's Center for Drug Evaluation and Research, the Division of Metabolism and Endocrinology Products has proposed a resubmission procedure that allows the independent Data Monitoring Committee's summary report of the Light Study interim analysis to form the basis of the resubmission of the Contrave NDA. Orexigen anticipates conducting the interim analysis and resubmitting the Contrave NDA in the second half of 2013 with potential approval in early 2014. | |
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News For OREX From The Last 14 Days Check below for free stories on OREX the last two weeks. |
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| May 8, 2013 | | 16:11 EDT |  | OREX | Orexigen reports Q1 EPS (21c), consensus (34c)
Reports Q1 revenue $857,000, consensus $890,000. | |
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