price target, page-44

I would have thought additional analysis of the Phase 2 trial data would allow them to identify higher probability responder groups. Part of phase 3 trial design is to establish the IFU to ensure success. Of course that is a 2 edge sword in that if you make it too specific you exclude a large potential patient population from being treated. I note that in OPT documentation, they claim that half the patients using current medications do not achieve meaningful clinical outcomes. Imagine, if potential non responders could be tested and filtered out before being treated - there goes half the income! I'm sure no one is looking too close into establishing this criteria, atm

But anyway, getting back to OPT-302, if we can learn anything from the numerous Sirtex trial failures, we would want to ensure we have recorded enough characteristics in the trial design to allow for a potential second chance approval on a smaller subset of responding patients. Hopefully, the second chance card won't need to be used, but at least we don't get a total wipe out and have to do another trial.