Published in Medical Letter on the CDC and FDA, November 24th, 2002
A 250-patient phase II trial is now under way that the companies hope ultimately will pave the way to a U.S. Food and Drug Administration approval, ImClone and Bristol said October 4, 2002. Larger trials are scheduled to begin next year.
The companies' application for approval to market the drug, which has shown promise in treating colon cancer without the side effects of chemotherapy, was rejected by regulators last December for scientific flaws in the clinical studies.
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