Merrion Pharmaceuticals, Inc. Finalises Its Phase III Development Program for Orazol(TM) in the USA
11/16/2010 9:40:59 AM
DUBLIN, Ireland, Nov. 16, 2010 (GLOBE NEWSWIRE) -- After recent consultation with the FDA in November 2010, Merrion is preparing for its Phase III study for Orazol™. If successful, the Phase III study will allow a new drug application for Orazol to be made under the FDA's abbreviated approval procedure section 505(b)(2) using a single Phase III study. The study will compare Orazol against placebo as an adjuvant breast cancer treatment with a primary endpoint of Disease Free Survival of patients with breast cancer.
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