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

To: Bob L who wrote (413)12/2/1999 9:10:00 AM
From: biowa  Read Replies (1) | Respond to of 666
 
Bob L,

<<How are they going to get clinical approval without dosimetry when the phase III used it?>>

If the dosimetry doesn't guide the treatment, then it may be considered merely another assessment technique. Zevalin is given in a dosage independent of dosimetry in the PIII isn't it? The big caveat to this is if the data shows a significant difference in response to the set dosage based on dosimetry.

biowa



To: Bob L who wrote (413)12/3/1999 3:08:00 PM
From: Gordon James  Respond to of 666
 
Bob L,

Thanks so much for the heads-up on the Zevalin paper! Very interesting stuff...

Not sure I agree on Zev toxicity being similar to Bex after my cursory view, but I need to study more. They mentioned 10% platelets < 10,000, where a recent number we got from Bex was 3%. But there may be some subtle differences in how AE's were reported.

Thanks again,
Gordon


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