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

To: keokalani'nui who wrote (1774)	12/31/2001 4:48:30 PM
From: 613	Respond to of 2515

How is a Q3 possible? This is my current problem with IMCL management. By their own admission, it will take 6-10 weeks after meeting with the FDA (2 more weeks) to refile. Then it is a minimum of 60 days (or is it 6 months.). BEST case, a 4 month delay. What about missing the FDA meetings? They don't meet every week for IMCL's convenience. I don't see how they make Q3 when Q2 was the original target. If it is Q4, other similar drugs are only 6 months away, instead of a year. Then they get into patent lawsuit issues with ABGX. Not a very clear future. Much explaining still needs to happen. They let their shareholders down. More importantly, they let cancer patients down. They were overconfident and/or simply ignorant.

To: keokalani'nui who wrote (1774)	1/2/2002 10:25:14 AM
From: mjsolomon	Read Replies (1) \| Respond to of 2515

"There apparently was plenty from the investigators and the IRC on their final conclusions, there just weren't any radiologic films, etc., to confirm that THEY did it right." Actually, all the films WERE included. The problem was that they didn't provide the steps leading from the films to the conclusions regarding the status of each patient. Key intermediate info would be measurements of the tumor on the films and calculations of tumor mass. As stated in the conference call, the FDA could recalculate this info from the films themselves, but they wanted to see the info (on probably thousands of films) right before them. Though not raw data, it certainly makes sense to have included this info. Mark