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Derma Sciences, Inc. (DSCI) on Track to Begin Phase 3 Program With DSC127 in December Following Meeting With FDA
10/22/2012 9:34:13 AM
PRINCETON, N.J.--(BUSINESS WIRE)--Derma Sciences, Inc. (Nasdaq: DSCI), a medical device and pharmaceutical company focused on advanced wound care, today reported that based on a meeting held last week with the U.S. Food and Drug Administration (FDA), the Company plans to begin its Phase 3 program in December 2012 in support of a New Drug Application (NDA) for DSC127 for treatment of diabetic foot ulcers. The FDA has expressed concurrence with the Company’s Chemistry, Manufacturing and Controls (CMC) program. “We had a productive meeting with the FDA and are working to finalize components of the development program discussed with the Agency during the meeting. The Agency provided helpful guidance, which our development team is now incorporating into our studies. We maintain our goal of beginning our Phase 3 program before the end of the year,” said Edward J. Quilty, president and chief executive officer of Derma Sciences. “Importantly, our drug manufacturing can proceed, and is in the final testing stage with the first doses expected to be available next month. We were very pleased with our discussion with the FDA and with the Agency’s recognition that the healing of diabetic foot ulcers represents a significant unmet medical need.”
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