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

To: aknahow who wrote (1885)	1/24/2002 9:41:23 AM
From: Arthur Radley	Respond to of 2515

George, This could be just one of those "urban legends", but I'm still puzzled as to why IMCL didn't follow the clearly laid out plans from the FDA. This patent issue(IF TRUE) could be the reason. James Frankel shared with me some info on this matter in a PM. I would ask him to share the same. My biggest rub in this whole issue is the fact we are dealing with peoples lives....and to give false hopes(if this is the case) is horrible.

To: aknahow who wrote (1885)	1/24/2002 10:39:56 AM
From: Arthur Radley	Respond to of 2515

BMY speaks...but says nothing about the issue..http://biz.yahoo.com/rf/020124/n24356261_1.html

To: aknahow who wrote (1885)	1/24/2002 1:35:12 PM
From: keokalani'nui	Respond to of 2515

The concern about the patent is that if properly controlled single agent and combination trials were conducted it might be found that c225 alone accounted for the significant portion of improvement (or that chemo accounted for it; doubtful at this point). If this were to occur the patent, which is for combination of any anti-neoplastic and any anti-EGFr Mab, would be valid but worthless in the marketplace. THAT is the patent issue that relates to the trial structure. IMCL tried to disarm that concern by recently stating that the mono trial showed 10.5% RR. (BTW, it is possible to read the cancer letter issue about the need for "other trials" as having been satisfied by the mono trial.) For those who think it is going to single digits--and I am not recommending imcl to anyone, short or long--you must be ready to face late April when all 3 HnN trial results (2 refractory, but smallish trials, and 1st line) will be known by the asco organization members some of whom work as securities analysts. Interest in this company really sprouted 2 (or 3? I forgot) years ago with its small, uncontrolled HnN results were disclosed at asco--they were, what is the word used, promising. There is no other cancer sporting greater density of EGFr receptors than HnN. Just a thought about timing. The Congressional investigation does not increase any risk. Their aim is to identify specific, isolated events that shed light on the need for increase or modified regulations and/or oversight. For them they will be looking to create POLICY. Now if the Justice Department got involved it would be a different matter. Wilder (sold 85% of my position after December conference call)