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Corixa Corporation (CRXA) Message Board

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  • toolatetrade toolatetrade Dec 6, 2002 3:55 PM Flag

    ? BEXXAR APPROVABILITY

    i don't think the fda would put bexxar back on active review status if the addional data was not
    convining. they would have held crxa on hold statas or denied the application.

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    • crxa was going to panel against the wishes of the FDA regardless of the change to active status of the application. The change to active status is a "non event", the panel had been set weeks before the change. Likely nothing more than horse trading prior to the inevitable panel. Keep in mind there is no new data, no new trial, just more interpretation of an outdated trial design from the mid 90's that was completed in 98/99. If you read the "Guidelines for dispute resolution above the division level" it states clearly that no additional data can be provided. The drug has activity, it is just not clear that they adequately demonstrated the risk/benefit. keep in mind c225 from imclone had activity. MAXM's maxamine was sent to panel for a public execution, don't over interpret an FDA panel being scheduled.

 

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