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CTIX -- Cellceutix Corporation
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[QUOTE]Originally posted by BooDog: [QB] Should be seeing the official launch of PIII sometime soon. Company Reports Successful End-of-Phase 2 Meeting With FDA Cellceutix Corporation (CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to announce that the U.S. Food and Drug Administration (FDA) has agreed to advancing brilacidin into phase 3 for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI). During a recently held End-of-Phase 2 Meeting, Cellceutix and the FDA discussed safety and efficacy data that support advancement into phase 3, as well as the basic elements of a phase 3 program. The planned phase 3 program would include two phase 3 ABSSSI studies, as required by FDA Guidance. In addition, the first study would include an interim analysis after a portion of the patients has been enrolled. This would provide an early assessment of both safety and efficacy. As part of the agreement, the Company would submit a Pediatric Study Plan (PSP) within 60 days of the End-of-Phase 2 Meeting. - See more at: http://cellceutix.com/brilacidin/#sthash.rjnpNBBb.dpuf [/QB][/QUOTE]
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