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Biotech / Medical : Corixa [CRXA] - cancer vaccines
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To: Vector1 who wrote (120)1/9/2002 8:18:35 PM
From: SemiBull  Read Replies (1) of 222
 
Corixa says Bexxar won't get FDA review in February

SEATTLE, Jan 9 (Reuters) - Biotech company Corixa Corp. (NasdaqNM:CRXA - news) said on Wednesday that a Food and Drug Administration panel will not be able to review next month the safety and efficacy of the company's drug Bexxar for the treatment of low-grade non-Hodgkin's lymphoma.

Corixa said the FDA advised the company that, as a result of the extensive amount of material submitted in response to the agency's complete review letter and subsequent discussions, February would not be an optimal time for discussion at the Oncologic Drugs Advisory Committee.

Corixa said the FDA has assured the company that it is continuing to work diligently on its review of Bexxar. The panel's next meeting is tentatively scheduled for June 6-7, but the agenda has not been set.

Although Corixa can provide no assurances, the company is hopeful that the safety and efficacy of Bexxar will be reviewed at that time. Bexxar is being co-developed by Corixa and GlaxoSmithKline Plc. (quote from Yahoo! UK & Ireland: GSK.L)

``Corixa remains committed to Bexxar and the promise it holds as a potential therapeutic for non-Hodgkins lymphoma patients,'' Corixa Chairman and Chief Executive Steven Gillis said in a statement. ``We will continue to assist the FDA in their ongoing review of our Biological License Application and look forward to ODAC review of our submission as soon as possible.''
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