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Genta withdraws Genasense NDA

Executive Summary

Genta is withdrawing its NDA for melanoma therapy Genasense, the company said May 13. The firm is requesting a meeting with FDA; co-developer Aventis plans to participate. FDA's Oncologic Drugs Advisory Committee voted 12 to 4 that Genta's pivotal trial for Genasense (oblimersen) did not show a "real effect" on progression-free survival (1"The Pink Sheet" May 10, 2004, p. 9)...
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