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Biotech / Medical : CLTR COULTER PHARMACEUTICAL

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To: Gordon James who wrote (420)	12/6/1999 8:55:00 PM
From: biowa	Read Replies (2) 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

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