Biotech Values

[DewDiligence]

Has ABBV elaborated on why they are running these [two] additional trials with Incivek/PegRiba as an active comparator?

ABBV hasn’t said, but I surmise that the main impetus for the two head-to-head trials vs Incivek +peg/riba is to facilitate marketing rather than to comply with anything requested by the FDA. It’s possible, however, that other regulatory agencies want the results of these trials or at least to know they are being conducted.

p.s. There are two (not three) ABBV trials vs. Incivek +peg/riba. The third trial that’s not part of ABBV’s initial NDA submission is the HIV/HCV co-infection trial, which will presumably have all-oral regimens in all trial arms.