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DewDiligence

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DewDiligence

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Re: DewDiligence post# 193828

Friday, 12/18/2015 10:24:19 AM

Friday, December 18, 2015 10:24:19 AM

Post# of 252609
MRK—EMA nixes “accelerated assessment” of 2-DAA* HCV regimen and will review the application on a standard timetable:

http://finance.yahoo.com/news/msd-provides-european-medicines-agency-130000985.html

The obvious reason for the change is the lack of an unmet medical need for an HCV regimen that’s inferior to Harvoni and V-Pak.

MRK still expects EU approval in mid 2016. In the US, the PDUFA date for this 2-DAA regimen is 1/28/16 (#msg-115740276).

*Elbasvir (NS5a) + Grazoprevir (PI).

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

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