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Genasense panel questioned

Executive Summary

In a Sept. 26 letter to Oncology Office Director Richard Pazdur, Emil Freireich (M.D. Anderson) expresses concern that FDA's Oncologic Drugs Advisory Committee "was comprised of specialists who frankly admitted having no experience" with chronic lymphocytic leukemia for the panel's review of Genta's Genasense; the panel recommended against approval of oblimersen Sept. 6 (1"The Pink Sheet" Sept. 11, 2006, p. 3). Genasense's positive impacted on a composite response endpoint in pivotal trials merits approval, Freireich states...

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