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Biotech / Medical : biotech firesales
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From: Ian@SI7/13/2011 4:59:36 PM
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TSPT closed near the low off 42.5%

1:36AM Transcept Pharma expects Complete Response Letter on Intermezzo New Drug Application based on teleconference with FDA (TSPT) 8.59 : Co announces that it expects to receive a Complete Response Letter from the FDA regarding the resubmitted NDA for Intermezzo on or before July 14, 2011, the PDUFA date assigned by the FDA for completion of the Intermezzo NDA review. This update from Transcept is based on a teleconference with the FDA during which the FDA expressed continued concerns about the safety profile of Intermezzo based on information in the resubmitted NDA. Until Transcept receives the anticipated Complete Response Letter, the company has limited information as to the full extent of FDA concerns.
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