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Re: NP1986 post# 135726

Wednesday, 05/23/2012 4:52:16 PM

Wednesday, May 23, 2012 4:52:16 PM

Post# of 257268
GILD submits MAA for standalone Cobicistat as a replacement for ritonavir:

http://finance.yahoo.com/news/gilead-files-european-marketing-application-200500656.html

The PR says a similar NDA submission to the FDA is planned in 3Q12.

Note: Cobicstat is a component of the 4-drug HIV regimen called Quad and is also a PK booster for Elvitegravir that enables it to be dosed qD. The PDUFA date for Quad is 8/27/12; the submission date for Elvitegravir is supposed to be in 2Q12.

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