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Re: DewDiligence post# 106451

Tuesday, 10/19/2010 9:36:49 PM

Tuesday, October 19, 2010 9:36:49 PM

Post# of 257580
More from GILD’s 3Q10 CC: The European MAA for ‘Btripla’ (the combination pill consisting of JNJ’s TMC278 and Truvada) was submitted on 9/3/10; with a typical review period, a decision will come in 4Q11. (The EMA does not have the equivalent of an FDA priority review for drugs that meet an unmet medical need.)

The Btripla NDA submission to the FDA is planned for Nov 2010; with a priority review, the FDA decision will come in 2Q11.

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