SmithKline/Coulter Bexxar
Executive Summary
FDA issues refuse-to-file letter Aug. 27. The iodine I 131 tositumomab BLA for relapsed or refractory low-grade B-cell non-Hodgkin's lymphoma was submitted June 30. FDA requested reformatting of certain sections and additional analyses of existing data; no new clinical trial information was requested. Coulter expects a new filing in six weeks