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frrol

12/15/18 9:51 PM

#251440 RE: farrell90 #251425

We were already granted Fast Track for B-OM. What I'm saying is I'd just like to hear it being affirmed and that we're going to be getting rolling reviews. More to the point, I'd like to hear that the FDA is excited about B-OM.

BTD is likely not happening given that over 60 days has passed since our application. Disappointed, and not holding my breath on it.