Bill Snyder

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ImClone, Genentech Jump on FDA News

11/04/03 - 02:13 PM EST

Bill Snyder

In a signal that regulators might give early approval to two new anticancer drugs, the Food and Drug Administration on Tuesday said that ImClone Systems'IMCL Erbitux and Genentech'sDNA Avastin won't be discussed at a committee meeting next month.

Both drugs were expected to be discussed at a mid-December meeting of the FDA's Oncologic Drug Advisory Committee. But according to a recorded message on the agency's phone hotline, neither colon cancer drug is on the agenda, and as reported on Monday by RealMoney reporter Adam Feuerstein, that's a hint that the agency doesn't feel the need to seek input from outside cancer experts and may approve the drugs before the end of the year.

However, the lack of an advisory committee discussion does not guarantee the quicker outcome.

After gaining as much as $2 early in the session, shares of Genentech were up 36 cents at $81.36 in afternoon trading. Similarly, ImClone, after spiking to $36.75 earlier in the day, was up 81 cents, or about 2%, at $35.30.





Bill Snyder



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