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Biotech / Medical : Imclone systems (IMCL) -- Ignore unavailable to you. Want to Upgrade?

To: RCMac who wrote (1764)	12/31/2001 10:13:47 AM
From: IRWIN JAMES FRANKEL	Read Replies (2) \| Respond to of 2515

I listened to the CC. The statement that seemed most telling went something like, "... the agency [FDA] does not believe the documentation is there ..." It was the one statement that was not "spin". ij Disclosure - No position now, if it drops enough I may enter.

To: RCMac who wrote (1764)	12/31/2001 3:18:49 PM
From: Arthur Radley	Read Replies (1) \| Respond to of 2515

Can you believe this? "Furthermore, ImClone said the FDA believed the documentation in the approval application was not sufficient to prove that patient tumors actually shrank after being treated with Erbitux. Simply put, ImClone said to the FDA, "Trust us." But the FDA said, "No, prove it." Waksal insisted that Erbitux has been proven to help cancer patients, and that it met or exceeded all its clinical trial goals. The problem, he adds, is that the FDA wants the "complete train of documentation" that would support these conclusions. But Waksal was also contrite, acknowledging that his previous boasts about the drug and the ease in which it would be approved have now come back to bite the company. Waksal said ImClone would be much more careful about making predictions. "We want to rebuild our credibility with Wall Street," he said. "