Merrion prepares Phase III study for Orazol in breast cancer treatment
 

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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