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DewDiligence

06/27/12 5:43 PM

#144643 RE: DewDiligence #142441

GILD submits NDA for “standalone” Elvitegravir in second-line HIV:

http://finance.yahoo.com/news/gilead-submits-drug-application-u-203000173.html

The word standalone in this context means that Elvitegravir is not being reviewed as a component of GILD’s 4-drug pill called Quad, but rather is intended to be used in a cocktail with a ritonavir-boosted protease inhibitor and a third agent that is not a PI or II.

Cobicstat, GILD’s proprietary PK-booster that is a component of Quad, is not needed in the cocktail described above because ritonavir performs the same function, allowing Elvitegravir to be dosed qD instead of BID. See #msg-75909916 for additional info.