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Can Tricky Elderly AML Population Justify Weak Data? Fate Of Genzyme's Clolar and Vion's Onrigin Rests With ODAC

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA's briefing documents for the Sept. 1 review suggest the single-arm Phase II trials are not sufficient; the wild card will be whether the panel thinks better trials can be done in that population.

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