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Biotech / Medical : IDPH--Positive preliminary results for pivotal trial of ID

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To: Howard Hoffman who wrote (1389)12/5/1997 10:53:00 PM
From: I. Luttichuys  Read Replies (1) of 1762
 
Howard... the thing to watch are the CD4 cells...
This has been a traditional problem with these kinds of therapies and this is why CE9.1 is out. During the earlier trials, I believe CD4 counts were relatively preserved but, in more extended trials, the counts fell and, CE9.1 was pretty much finished. I do not know exactly why this problem appeared only in subsequent trials. It may be something which was done differently during scale-up etc... hard to say but, anyway, you will notice IDEC makes it a point in the recent announcement to point out that CD4 cell populations were not disturbed. Will things stay that way... I don't know.
The reason Rituxan was a non-event was because the approval was widely anticipated. No one in my circles doubted it's approval for even a minute... for over a year, at least... everyone knew it would pass. The FDA worked very closely with IDEC on this one... it's not passing would have been an embarassment.
BENNETT
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