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oc631

04/20/11 7:07 PM

#118593 RE: DewDiligence #118592

Exactly right! You must have listened to today’s CC; given your interest in the HCV arena, I should have expected that you would be listening and I should not have labeled the quiz high difficulty :- )




Actually I didn't listen to the call. How do you think the FDA will view this strategy?
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jq1234

04/20/11 8:03 PM

#118600 RE: DewDiligence #118592

For the record, GILD said the NDA submission for Quad (Elvitegravir + Cobicistat + Truvada) will come in 1Q12 and the submission for Elvitegravir + Cobicistat without Truvada will come in 2Q11. I can’t recall another instance in which a combination was submitted before one of its components



Do you mean Elvitegravir + Cobicistat without Truvada NDA will come in 2Q12, not 2Q11?