said the Food and Drug Administration accepted and granted accelerated review to their biologics license application for the colon-cancer drug Erbitux.
The review, which could provide closure for a drug that has generated controversy over both its efficacy and its bit part in a famous insider-trading scandal, should be completed by Feb. 13, 2004.
Acceptance of ImClone's BLA doesn't denote clearance to market the drug, just that the data is complete. It's a significant milestone for ImClone, however, because its first effort to file the drug was turned down by the FDA.
That rejection sparked one of the great insider-trading scandals of the last decade as ImClone founder Sam Waksal tried to unload shares in the company before the news became public. He also allegedly tipped several family members and Martha Stewart, whose trial is pending.
Sam Waksal began a prison sentence earlier this year. On Friday, his 82-year-old father Jack was slapped with civil charges for allegedly selling more than $8 million of ImClone stock on his son's illicit advice.
ImClone was recently up $1.50, or 3.6%, to $43.50.
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