My diligence indicates Provectus is pursuing accelerated approval in its liver Phase 2/Phase 3 trial under a special protocol assessment. It is possible, however, as Tim Scott mentioned in his September presentation at the Rodman & Renshaw conference, that the study could be just a Phase 2 trial. As a result, this trial might not qualify for SPA or AA. The ultimate approach and trial design will depend on management's interactions with the FDA.
In either case, I expect the eventual liver trial will have received significant input from key opinion leaders and the FDA. Given the results Dr. Scott tantalized the audience with at the conference, I am sure big pharma is most focused on the trial providing randomized data (i.e., sorafenib vs. sorafenib + PV-10). It would seem everything else (clinical data) is gravy.
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