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Cadence Pharmaceuticals Announces Positive Topline Results of Phase III Clinical Trial of Acetavance in Laparoscopic Surgery
Date:12/17/2008

this press release due to the risks and uncertainties inherent in the company's business, including, without limitation: the outcomes of final analyses of data from the company's clinical trials of Acetavance may produce negative or inconclusive results, may differ from the initial analyses, or may be inconsistent with previously conducted clinical trials, and the Food and Drug Administration (FDA) may not agree with Cadence's interpretation of such results; the FDA may require Cadence to complete additional clinical, non-clinical or other requirements prior to the submission or the approval of NDAs for Acetavance; data from clinical trials of Acetavance may demonstrate inadequate therapeutic efficacy, and clinical trial data, as well as reports of adverse events from countries where intravenous acetaminophen is already approved and commercialized, may indicate that the prevalence or severity of adverse side effects is greater than anticipated; the company may experience delays in completing important pre-commercialization manufacturing development activities for Acetavance, and may be required to perform additional pre- clinical or clinical testing prior to submitting, or obtaining approval of, an NDA for this product candidate; the third parties on whom Cadence relies to assist with the development program for Acetavance, including clinical investigators, contract laboratories, clinical research organizations and manufacturing organizations, may not successfully carry out their contractual duties or obligations or meet expected deadlines, and the quality or accuracy of the non-clinical, clinical and manufacturing data generated by such third parties may be of insufficient quality to include in the company's regulatory submissions; Cadence may require substantial additional funding to complete its development program for Acetavance and, if approved, to successfully launch this product candidate, and the company may not be able to raise su
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SOURCE Cadence Pharmaceuticals, Inc.
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