There are several reasons why. The company has done phase 2/3 testing here in the US, but have also tested internationally - all with great results. The company reported statistically significant improvement in repairing chronic heart disease - the number one cause of death - and there are no real alternatives.
Next, the FDA had the option to deny the application. Instead they asked for additional information. This is a really good sign.
USRM was required to apply for reactivation of their trials before or with the RMAT application. The FDA reviewed the trails - a pretty rigorous review - and went ahead and reactivated. This is an even better sign.
The FDA's job is to find and approve devices or drugs that are safe and effective. For those drugs or devices that save lives and fill an unmet need, they will go the distance.
Oh yea, and the new head of the FDA is a strong supported of Adult Stem Cells.
Market Data 
Markets 
AI
