Repost of CEO blog
Posted by U.S. Stem Cell, Inc
Dear Shareholders and Friends,
U.S. Stem Cell, Inc. has seen many exciting accomplishments in April. We have curated new partnerships, finalized investments, and received updates on our RMAT designation from the Food and Drug Administration (FDA).
We have recently partnered with Advanced Stem Cell RX in a strategic alliance to commercialize our proprietary applications and protocols. Advanced Stem Cell RX will aid us in implementing U.S. Stem Cell, Inc. programs into qualified practices and clinics in over 20 different states. They will be utilizing our technology to treat patients suffering from degenerative disorders.
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.
For example if "late March" actually meant 3/31 then today would be 60 days.
I expect to know something this week.
