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Re: shaman919 post# 55257

Thursday, 04/27/2017 12:34:45 PM

Thursday, April 27, 2017 12:34:45 PM

Post# of 106837
Actually they submitted application on January 27 for RMAT application asking for the Marvel trial to be reinstated as well as MyoCell as part of MyoCell ... Around end of March inquired for more info on the MARVEL TRIAL (which could take up to another 60days) and April they reinstated Marvel II/III trial (which they asked for) and still reviewing RMAT application for MyoCell..
Here is the Link BLOG
[url][/url][tag]http://us-stemcell.com/ceo-blog-exciting-accomplishments-in-april/[/tag]

Here it is from the Blog :
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.