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dangerM

06/22/17 4:58 PM

#212024 RE: DewDiligence #212016

Thx! I wasn't aware of the about 2 month lag.

Anyway, I was wondering about the repercussions on the timeline of all the ensuing activities (from manufacturing, channel loading, marketing, hoping for timely update of treatment guidelines, ...) in case of a surprisedly fast decision. So they they have two months now (I expect the opinion to be positive :-)
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DewDiligence

06/23/17 9:37 AM

#212040 RE: DewDiligence #212016

CHMP approves ABBV/ENTA’s Maviret (G/P) for HCV genotypes 1-6:

http://ir.enanta.com/news-releases/news-release-details/enanta-announces-abbvie-receives-chmp-positive-opinion-mavirettm

The CHMP approval will be followed by EU Commission rubber-stamping in about 2 months, at which time ENTA will receive an undisclosed milestone payment from ABBV (my estimate is $30M).

The treatment duration is 8 weeks for treatment-naïve patents w/o cirrhosis and 12 weeks for other patients.