If eribulin and ixabepilone have shown no response in this patient population, than what would the control arm be in the confirmatory Phase III? Could it just be "investigator's choice?" as in the Phase II?
Dr, Vahdat said "patients were lined up" for the eribulin trial, so I would expect enrollment to proceed quickly. Do you agree?
How long does it normally take for the FDA to sign off on the Phase III design for something like this? How soon could investors expect the trial to be up and running? Can it take more than a year?
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