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DewDiligence

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Re: Bio_pete post# 802

Wednesday, 05/08/2019 7:13:24 PM

Wednesday, May 08, 2019 7:13:24 PM

Post# of 9090

I don't understand why they wouldn't file with the smaller vial & then file a supplement for the 100 unit vial.

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.

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

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