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Orexigen Resubmits Contrave New Drug Application
Date:12/11/2013

risk profile for Contrave; and the execution of the Contrave U.S. launch by Takeda; Orexigen's plans to seek a commercialization partner in territories outside of North America; and the timing of the submission of the CSR for the interim analysis. The inclusion of forward‐looking statements should not be regarded as a representation by Orexigen that any of its plans will be achieved. Actual results may differ materially from those expressed or implied in this release due to the risk and uncertainties inherent in the Orexigen business, including, without limitation: the possibility that the FDA determines not to initiate review of the Contrave NDA until it has received the CSR for the interim analysis; the SPA is not binding on the FDA if public health concerns unrecognized at the time the SPA agreement was entered into become evident, other new scientific concerns regarding product safety or efficacy arise, or if Orexigen fails to comply with the agreed upon trial protocol; the potential for the FDA to not approve Contrave even after meeting the prespecified threshold and resubmitting the NDA; the possibility that public disclosure of the results of the interim analysis would later be deemed to jeopardize the integrity of the Light Study potentially resulting in the requirement to conduct additional, costly studies; additional analysis of the interim results or new data from the continuing Light Study, including safety-related data, may produce negative or inconclusive results, or may be inconsistent with the conclusion that the interim analysis was successful; the potential that the interim analysis may not be predictive of future results in the Light Study; the potential for early termination of Orexigen's North American collaboration agreement with Takeda; the results from the interim analysis may not be sufficient to satisfy or respond to the Day 120 List of Questions from the EMA or any other data requirements of the EMA in conn
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SOURCE Orexigen Therapeutics, Inc.
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