There are 9 phase-3 trials in all: 6 trials that comprise the initial NDA submission in 2Q14 and 3 trials for subsequent use.
Has ABBV elaborated on why they are running these three additional trials with Incivek/PegRiba as an active comparator? By all indications the ABBV combo should prove superior. Could the data from these trials establish the ABBV combo as the next SOC under future FDA guidance?
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