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Re: ciotera post# 193101

Wednesday, 07/01/2015 9:08:02 PM

Wednesday, July 01, 2015 9:08:02 PM

Post# of 251596

GILD—I wonder why they chose to use the priority-review voucher for R/F/TAF (improved Complera) vs. E/C/F/TAF (improved Stribild)?

The reason may be that Complera-TAF’s being the last of the three* NDA submissions for TAF-based regimens under GILD’s control makes it the one that determines when GILD will be able to launch a full-fledged marketing campaign that promotes all three products.

Moreover, GILD purchased the priority-review voucher on 11/19/14 (#msg-108618217)—thirteen days after the NDA submission of F/TAF on 11/6/14 (#msg-107899029). I’m not sure whether a sponsor can apply a priority-review voucher after an NDA/BLA submission has been made.

*Stribild-TAF (E/C/F/TAF), Truvada-TAF (F/TAF), and Complera-TAF (R/F/TAF); JNJ has the commercial rights to “Prezista-TAF” (#msg-109435833).

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