US Stem Cell Inc (USRM)

[TheHungryHippo]

Nowhere does it say or has it said that USRM has received any decision from the FDA.

You have people putting misleading articles out there..

like this one:

https://ipscell.com/2017/06/us-stem-cell-bid-for-fda-rmat-rejected/

but read this quote and ask yourself this:

If we have not received a decision from them, then what if we are the "one" out of the "19"

“Thanks to the 21st Century Cures Act, FDA now has a new designation for regenerative medicines, known as the regenerative medicine advanced therapy (RMAT) designation. As of last week, Marks said there have been 19 requests for RMAT designations, 18 of which CBER has acted on, and four of which have been granted…’

Unless US Stem Cell, Inc. is the 1 out of the 19 applications on which the FDA has not acted, then it’s not looking promising for their RMAT just based on the odds. Another possibility is the FDA did not reject it, but asked US Stem Cell for a lot more data and that constitutes “acted on”.