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Lymerix Two-Month Dose Expected By Mid-2000, Pediatric Data By Year-End

Executive Summary

SmithKline Beecham's Lymerix two-month accelerated dosing regimen could receive FDA approval in the first half of 2000, Jean-Pierre Garnier, PhD, said Sept. 16 at the Bear Stearns health care conference in New York City.

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New NDA filing for the iodine I 131 tositumomab product is no longer expected by mid-October, CEO Michael Bigham told analysts Sept. 28. The Aug. 27 "refuse-to-file" letter from FDA required Coulter to reformat selected data sets, reorganize certain analyses and provide archival images. Bigham said a meeting the company requested with FDA will not take place until mid-October, delaying the resubmission. Co-marketing partner SmithKline Beecham has indicated that it is helping Coulter with the submission (1"The Pink Sheet" Sept. 27, p. 22)

Coulter Bexxar

New NDA filing for the iodine I 131 tositumomab product is no longer expected by mid-October, CEO Michael Bigham told analysts Sept. 28. The Aug. 27 "refuse-to-file" letter from FDA required Coulter to reformat selected data sets, reorganize certain analyses and provide archival images. Bigham said a meeting the company requested with FDA will not take place until mid-October, delaying the resubmission. Co-marketing partner SmithKline Beecham has indicated that it is helping Coulter with the submission (1"The Pink Sheet" Sept. 27, p. 22)

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