BrainStorm Cell Therapeutics Inc. Takes Initial Steps Toward FDA Submission
NEW YORK & PETACH TIKVAH, Israel--(BUSINESS WIRE)--BrainStorm Cell Therapeutics Inc. (OTCBB:BCLI), a developer of autologous adult stem cell technologies and therapeutics, announced today that the Company has completed a preliminary meeting with representatives of the FDA Office of Cellular, Tissues and Gene Therapies, to discuss BrainStorm's preclinical research program in Parkinson's Disease. The meeting was a prelude to a future IND filing for entering human trials in the area of Parkinson's Disease. FDA representatives addressed the results of the Company's four month data in a murine Parkinson's model and the Company's basic approach to preclinical proof of concept. FDA suggested confirmatory studies in a second species of experimental animals to provide more data on safety and efficacy of the procedure, before the initiation of human trials. Since the meeting was voluntary from a regulatory perspective, no PDUFA clocks attach to the next phase of contact between the Company and FDA.