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Article: Corixa Files Request for Formal Dispute Resolution With FDA on BEXXAR; In its Appeal, Company Requests Appearance at ODAC Meeting.
- Article from:
- Business Wire
- Article date:
- May 31, 2002
CopyrightCOPYRIGHT 2002 Business Wire. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Business Editors & Health/Medical Writers
BIOWIRE2K
SEATTLE & PHILADELPHIA--(BW HealthWire)--May 31, 2002
Corixa Corp. (Nasdaq: CRXA) and GlaxoSmithKline (NYSE: GSK) today announced that Corixa has filed a request for formal dispute resolution, appealing the position articulated by U.S. Food and Drug Administration (FDA) on the approval status of BEXXAR(R) in its complete review letter dated March 12, 2002.
Corixa also requested the opportunity to present data on the safety and efficacy of BEXXAR in the treatment of relapsed or refractory low-grade and transformed-low grade non-Hodgkin's lymphoma (NHL) to a meeting of the Oncologic ...