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ImClone Could Get Erbitux Approved Within a Year
The Food and Drug Administration may allow ImClone Systems (IMCL Quote) to resubmit its experimental cancer drug Erbitux for approval using salvaged data from its U.S. clinical trial, in addition to data expected from an ongoing test in Europe.
Such a plan could have FDA regulators deciding on Erbitux's approvability by next spring, one year behind schedule.
This new approach for Erbitux came out of Tuesday's highly anticipated meeting between ImClone executives, its partner Bristol-Myers Squibb(BMY Quote) and FDA officials.
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