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Transcept Pharmaceuticals Announces Preliminary Results From the Intermezzo® Highway Driving Study
Date:10/18/2010

ed to be included in the Intermezzo® NDA resubmission; Intermezzo® being the first commercially available sleep aid in the United States in its target indication; the ability of the highway driving study results to favorably differentiate Intermezzo® from other sleep aids and of Intermezzo® to become an important treatment option for patients; the sufficiency of Transcept cash resources to address the anticipated issues relating to the resubmission of the Intermezzo® NDA and to complete the planned Phase 2 study of TO-2061; and timing estimates to begin a Phase 2 study of TO-2061. Transcept may not actually achieve the plans, carry out the intentions or meet the expectations disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Transcept makes, including the following: new information arising out of Intermezzo® clinical trial results, including the highway driving study, and the potential for the FDA's view of such data to differ from the Transcept interpretation; changing FDA guidance with respect to the driving study, proposed unit dose packaging for Intermezzo® and other aspects of the potential resubmission package for the Intermezzo® NDA; delays in the Intermezzo® approval process and the development progress of competitive products; the outcomes from planned Phase 1 studies of TO-2061 and discussions with the FDA about our development plans for TO-2061; the sufficiency of the anticipated content of the planned Intermezzo® NDA resubmission to support FDA approval; unforeseen expenses or delays in our currently planned d
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SOURCE Transcept Pharmaceuticals, Inc.
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