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FDA's Oncologic Drugs Advisory Committee will re-examine valrubicin (AD32) for patients with biopsy-confirmed carcinoma in situ of the bladder refractory to Bacillus Calmette-Guerin vaccine on the afternoon of Sept. 1. The committee recommended against approval of Valstar (NDA 20-893) June 1 because the "complete response" endpoint was viewed as an insufficient measure of efficacy ("The Pink Sheet" June 8, p. 26). The company has submitted a reanalysis
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