Biotech Values

[DewDiligence]

Re: IDIX / NVS' opt-in timeframe on IDX184

I assume the 90-day window starts once the monotherapy results are released. Won't it take months just to recruit patients for the combo study (or is this just a follow-on trial using existing patients from the monotherapy?), let alone to enroll them, run the trial, then compile and report the results?

The IDX184 combo study is not merely an extension of the mono study, so it does have to recruit all new patients. However, IDIX will not require a time-consuming new sign-off by the FDA to start the combo study unless there is some bizarre safety problem in the mono study. The design of the combo study has already been broached with the FDA, and it is the same design that has been employed in the phase-2 studies of several other oral HCV antivirals.

Moreover, the go/no-go decision by IDIX to proceed to the combo study will be relatively simple and won’t require a lot of data analysis. Hence, IDIX can start the combo trial while it is preparing the contractually mandated formal submission to NVS of the results of the mono study. The 90-day clock starts when IDIX makes the formal submission to NVS, not when IDIX announces the top-line data from the mono study.

Finally, the combo study may have some kind of interim look to allow NVS to get a better read on IDX184 before deciding whether to opt-in.