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Clinic Roundup


Monday, June 20, 2011
Titan Pharmaceuticals Inc., of South San Francisco, received a letter from the FDA providing comments on the revised statistical analysis plan (SAP) for a confirmatory Phase III study of Probuphine in patients with opioid dependence. Although the data review at all clinical sites is complete and the blinded dataset ready for analysis, Titan said it will need to delay the analysis briefly to allow time for a discussion with the FDA and subsequent modification of the SAP as necessary.

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