US Stem Cell Inc (USRM)

[Gsdubb]

No it won't be easier.
It is a biologic. Period
The BLA is a similar process for biologics and as the NDA process is for drugs which are synthetic and manufactured.

My point again
However, an autologous stem cell phase 3 trial as in the case of Myocell doesn't require as many enrollments as say a new drug as Myocell is from your own body.

This all started as I was trying to explain the major cost difference

Of having thousands of patients versus a few hundred.

Drug or allogeneic stem cells require more.

Therefore phase 3 trials will cost less for Bioheart.

The approval process will be just as stringent as a drug.