Before posters here draw too many inferences from the recent granting of the FDA orphan drug designation, it is probably worth reiterating that even preclinical drugs have been awarded that status as NanoEngineer alluded to in post 107745.
Secondary outcome measure are hinting positive with the company securing Orphan Drug status and planning a Phase 2/3 for Ovarian Cancer. Without Secondary indications of efficacy, this move wouldn't make sense.