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BioSante says FDA special protocol assessment for LibiGel completed

money.cnn.com

BioSante Pharmaceuticals Inc. (NASDAQ:BPAX) said Tuesday that it reached and completed a special protocol assessment with the Food and Drug Administration for its Phase III safety and efficacy trials for LibiGel in the treatment of female sexual dysfunction.

The Lincolnshire, Ill.-based developer of hormone therapy products said the process and agreement affirms that the FDA agrees that the LibiGel Phase III clinical trial design, endpoints, sample size, planned conduct and statistical analyses are acceptable to support regulatory approval.

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