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Tuesday, July 12, 2016 12:43:55 PM
The trial is powered to show a 2.1 month improvement in PFS over a control arm estimate of 3.5 months PFS.
The PR said this about PFS.
For the current evaluation, the study did not show a significant difference between aldoxorubicin and investigator's choice therapy for PFS, with a median of 4.17 months and 4.04 months, respectively, for the study's primary endpoint (hazard ratio: 0.91).
So they're needing to get a final PFS result of at least 6.14 months. I just don't see how that's going to happen.
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