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iwfal

05/17/19 10:44 PM

#835 RE: DewDiligence #806

That was asked and answered on the CC. Dan Browne said that going the sBLA route for the 100U vial would have delayed FDA approval of the 100U vial by about two years, so RVNC thought a small delay for the dual-vial BLA was a better option.



Common theme for Browne? Not a pay-as-you-go, but instead an eyes bigger than stomach guy.?