Biotech Values

[DewDiligence]

(Quiz here!)—More on GILD’s ‘Btripla’ from today’s 3Q10 CC: To mitigate the potential backlash from clinicians over TMC278’s unexpectedly high rate of viral breakthrough seen in phase-3 (#msg-52471333), GILD will run two phase-3b trials (effectively phase-4 trials that are started prior to a drug’s approval for marketing). One phase-3b will test Btripla vs Atripla and, unlike the completed phase-3 study of Btripla vs Atripla, it will be open-label.* A second phase-3b will start all patients on Truvada plus a PI to be determined and then randomize patients with suppressed VL to either continue on the same regimen or switch to Btripla. These phase-3b trials will start as soon as GILD gets the FDA signoff on the designs.

*Why open-label? I’ll make the answer a quiz.