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MedResCollab

07/06/19 12:31 PM

#200166 RE: HDGabor #200164

HDGabor, well at least on the AC meeting we should have a clear idea over the next two weeks. On our CP, we think it will have a modest impact, but an impact nonetheless. If you analyze past CPs that weren’t filed in an attempt to thwart generic entry, the statistics are more favorable. We also have evidence that private dialogue has been effective with the agency, and have previous to our submission engaged in that route as well.

Regards,
-MRC