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SUNDAY, NOVEMBER 8, 2009
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PREMIUM NEWS ARCHIVE

Cougar Biotechnology Announces Agreement with FDA on Special Protocol Assessment for Phase III Trial of CB7630 Abiraterone Acetate in Chemotherapy Naive Castration Resistant Prostate Cancer Patients.

Article from: Cancer Weekly Article date: February 24, 2009

Cougar Biotechnology, Inc. (NASDAQ: CGRB) announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for its planned Phase III clinical trial of the Company's lead drug candidate CB7630 (abiraterone acetate) in patients with chemotherapy naive castration resistant prostate cancer. The SPA is a written agreement between the Company, as the trial's sponsor, and the FDA regarding the design, endpoints, and planned statistical analysis approach of the Phase III ...

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