US Stem Cell Inc (USRM)

[Barinvest]

Regarding the 21st Century Cures Act: "Regenerative medicine"

Senator Mark Kirk of Illinois, who had a stroke in 2012, introduced the REGROW Act earlier this year, to expand treatments for stroke victims and people suffering from Alzheimer’s, Parkinson’s and diabetes. Kirk’s legislation, which GOP leaders tried to include in the Cures Act, would have permitted the FDA to approve stem cell treatments conditionally, without a large, final-stage clinical trial that is usually required.

But many researchers argued that stem cell therapies are still in the early stages of safety and efficacy, and urged Congress to hold off giving FDA such a mandate.

The final Cures draft does not allow new regenerative medicine products, which include stem cell therapies, to skip the Phase 3 trials. But it does permit FDA to grant them accelerated approval if they can show that surrogate endpoints might indicate the drug works, subject to further study."
Source
https://www.statnews.com/2016/12/05/21st-century-cures-act-winners-losers/