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Endocyte And Accelerated Approval

Executive Summary

Endocyte CEO Ron Ellis shows no hard feelings that EC145 was turned down for accelerated approval, although he clearly thinks the PRECEDENT trial was well designed and that its median PFS results showed a sufficiently robust improvement over the control to warrant AA. Jason Kantor at RBC is not surprised. He says that, by FDA’s lights, robustness of data can mean different things: magnitude of variance, statistical rigor. “Endocyte showed benefit in a single trial – but that’s not as robust as when a larger Phase III trial confirms your findings.”
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