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Nabi Biopharmaceuticals Reaches Special Protocol Agreement With FDA for NicVAX(r) Phase 3 Trial Protocol
ROCKVILLE, Md., Dec. 23, 2008 (GLOBE NEWSWIRE) -- Nabi Biopharmaceuticals (Nasdaq:NABI) announced it has reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for a pivotal Phase 3 clinical trial of NicVAX(r) (Nicotine Conjugate Vaccine), the company's innovative and proprietary investigational vaccine to treat nicotine addiction and prevent smoking relapse. The SPA is a process by which sponsors and the FDA reach agreement on the design and size of clinical trials. It is intended to form the basic foundation to support approval of a New Drug Application.