US Stem Cell Inc (USRM)

[NoMoDo]

They actually don't need an active drug trial as long as they meet certain designation criteria. The FDA has approved many drugs and devices after just completing phase 1 - look at HIV drug history. Myocell was very far along when they ran out of money.

USRM was in a world of financial hurt until pretty recently. Getting the drug reactivated at some point was wise as RMAT conditional approval requires continued reporting of results for 6 month period after the drug or device is marketed.

My speculation and only speculation mind you - is that the FDA asked USRM how they intended to provide follow up results if they were approved to market their product. USRM then applied for reactivation as a response. And just now got it.