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Gsdubb

08/14/14 5:12 PM

#10918 RE: Dragon Lady #10915

Biologics are approved through the BLA process which is just as stringent as the NDA process. The difference is the safety shown with autologous stem cells thus far hence the lower number of enrollment needed. Look at Cardio3 again autologous Bioheart direct competitor.
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Gsdubb

08/14/14 5:21 PM

#10919 RE: Dragon Lady #10915

I would consider a stem cell a "cell based therapy" wouldn't you?