Monday, November 24, 2014
BioRestorative Therapies Schedules Pre-IND Meeting with FDA
JUPITER, Fla., Nov 24, 2014 (BUSINESS WIRE) Clinical Development Meeting with FDA BioRestorative Therapies, Inc. ( BRT or the Company ) (OTCBB:BRTX), a life sciences company focused on adult stem cell-based therapies for various personal medical applications, announced that a Pre-IND (Investigational New Drug) meeting with the Center for Biologics Evaluation and Research ( CBER ) of the U.S. Food and Drug Administration ( FDA ) has been scheduled for December 19, 2014. The purpose of the meeting is to obtain FDA s input regarding BRT s plans for the development of brtxDISC(TM), the Company s novel autologous stem cell product for the treatment of chronic lumbar disc disease ( cLDD ). In preparation for the meeting, the Company has submitted a Pre-IND Package to the FDA that describes the information BRT proposes to include in the brtxDISC(TM) IND planned for submission in 2015. The IND is the regulatory vehicle that will allow for the initiation of clinical trials with brtxDISC(TM) fo
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