Fibrocell Announces Positive Feedback from Type B End-of-Phase 2 Meeting with FDA on Phase 3 Clinical Trial Design for FCX-007
FIBROCELL SCIENCE INC COMMON (FCSC)
NASDAQ:AMEX Investor Relations:
fibrocell.com
Company Research
Source: GlobeNewswire
- Phase 3 clinical trial, named DEFI-RDEB, is expected to commence in the second quarter of 2019 - - Additional data from Phase 1/2 clinical trial demonstrates FCX-007 continues to be well tolerated with continued positive trends in wound healing - - Company reports full year 2018 financial results - - Conference call & webcast scheduled at 8:30 a.m. EDT today - EXTON, Pa., March 27, 2019 (GLOBE NEWSWIRE) -- Fibrocell Science, Inc. (Nasdaq: FCSC), a gene therapy company focused on transformational autologous cell-based therapies for skin and connective tissue diseases, today announced the completion of a Type B end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) to discuss the design of a Phase 3 clinical trial for FCX-007, the Company’s gene therapy candidate for the treatment of recessive dystrophic epidermolysis bullosa (RDEB), to support a Biologics License Application (BLA) filing. In addition, the Company reported additional positive safety and wound
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