Published in Women's Health Weekly, April 14th, 2005
Based on the evidence provided by the company in its pre-IND meeting with the FDA, the company was granted the right to proceed directly into a phase II dose ranging study upon concurrence with the protocol submitted, as well as conduct only a single phase III study.
Jack E. Stover, president and CEO of Antares Pharma, commented, "The submission of Antares Pharma's first proprietary pharmaceutical submission to the FDA is an...
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