An MAA is the EU’s version of a new drug application. GILD’s MAA submission is a few weeks early relative to GILD’s prior guidance for 4Q10 submissions to both the EMA and FDA; GILD’s NDA submission for TMC278+Truvada is awaiting the FDA’s acceptance for review of JNJ’s separate NDA for standalone TMC278, which was submitted on 7/26/10 (#msg-52656751).
The TMC278 + Truvada combo pill has been referred to as Btripla by some investors and analysts because it is intended to compete with the blockbuster, Atripla (#msg-54039347).
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