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.
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