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frrol

12/15/18 1:57 PM

#251406 RE: PlentyParanoid #251405

There is very little likelihood of B-OM not getting a green light from the FDA. The issue is if the green light is 'unconditional' and if it gets expedited. BTD is now highly unlikely (we did not hear about any app resubmission) but it would be good to hear that the FDA affirmed that it is specifically under FTD and will get rolling reviews. The tone and posture of the FDA at the EOP2 will be of interest. There will be P3 cost and time implications, both of which the potential partner will want to hear before signing a deal.