US Stem Cell Inc (USRM)

[ShadyMaguire]

FDA by May 27th - On January 27, 2017, U.S. Stem Cell, Inc. applied for the FDA’s new Regenerative Medicine Advanced Therapy (RMAT) designation for the MyoCell™ product as part of the MARVEL trial. After application, the FDA is given 60 days to review it or request additional information. In late March, the FDA requested additional information in order to reinstate our IND (MARVEL trial)—which has been reinstated to active status. Please note that each time more information is requested, the 60-day timeline resets and the FDA is afforded additional regulatory processing time. Currently, U.S. Stem Cell, Inc. is operating within the regulatory timeline and is actively working with the FDA to quickly and effectively fulfill requests for supplementary materials. We will continue to keep our base informed on any FDA communications that affect this timeline. (from CEO Blog)