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henrym28

05/08/19 7:05 PM

#804 RE: Bio_pete #802

Maybe the 100U vial is a red herring. There was no clear explanation for this on the CC. An analyst asked for more specifics as to essentially what the point of this is and why it's coming up now. Dan did not provide a clear explanation. These guys are not inspiring much confidence here.
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DewDiligence

05/08/19 7:13 PM

#806 RE: Bio_pete #802

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.