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Biotech / Medical : CLTR COULTER PHARMACEUTICAL -- Ignore unavailable to you. Want to Upgrade?

To: Gordon James who wrote (420)	12/3/1999 8:31:00 PM
From: WTDEC	Read Replies (1) \| Respond to of 666

Gordon, Thanks for a series of excellent posts...very much appreciated by us less technical types. Looking forward to any developments at ASH you might share with us. Enjoy your stay in N.O. Best regards, Walter

To: Gordon James who wrote (420)	12/3/1999 9:12:00 PM
From: Bob L	Respond to of 666

Thanks for the summing up and tying together of the various statements on dosimetry, Gordon. Excellent as usual. It would just seem that if they decided not to treat a patient based on what they saw with Indium that they are a bit short of breezing through FDA approval without Indium imaging. As usual, we are left to wait and wonder . . .

To: Gordon James who wrote (420)	12/4/1999 12:16:00 PM
From: Bob L	Respond to of 666

A Reuters article on CLTR today: biz.yahoo.com The main point of the article is a report of good results for Bexxar with Fludarabine at ASH.

To: Gordon James who wrote (420)	12/6/1999 8:55:00 PM
From: biowa	Read Replies (2) \| Respond to of 666

Gordon, <<Patients received rituximab and IDEC-In2B8 on day 0 followed by gamma camera imaging on days 0 through 6. If the predicted delivered dose of radiation to any nontumor organ was more than 20 Gy or if the dose to the bone marrow was more than 3 Gy, no treatment with IDEC-Y2B8 was to be administered>> What I found more interesting than the one excluded patient is the fact that dosimetry is being used as a safety screen for inclusion. That should be interesting to finesse with the FDA, "Well, yes we did think it was important to not treat patients in the study with these dosimetry results, but since we only enrolled one patient who it would be a problem..." biowa