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

To: JEB who wrote (283)	2/14/1999 1:32:00 PM
From: Arthur Radley	Respond to of 2515

Yes! It is normal for them to ask the FDA to look at each stage of the process to see if they have any issue with protocal or for that matter any issue they wish to look at. However, it is after Phase III that they(FDA) start the long hard look at the drug for approval with all issues on the table. Early on, the FDA is mainly concerned with safety issues. It would be great to think that if a drug completes Phase III it will be a cinch for final approval, but you only have to look back at CLPA a few weeks ago to see the perils that could still be ahead for IMCL or any drug company. I'm pulling for IMCL, as all indications look VERY positive for their work.