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Biotech / Medical : Biotransplant(BTRN)
BTRN 35.57-0.8%Nov 3 4:00 PM EST

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To: michael_f_murphy who wrote (1347)6/26/2002 6:41:24 PM
From: aknahow  Read Replies (1) of 1475
 
Thanks for the link. The meat IMO begins with the FDA presentation, especially on page 121 and 122.

I also read p 320 to the end 350? where the committee more or less addresses scope of use, labeling, post trial monitoring. I did not find what I considered a response to the questions raised by the FDA spokesman, by the committee.

When the FDA says, "you really have to wonder about that interpretation" in relation to BGEN's claim for a nine month median duration when the data show a return to placebo levels at nine months one wonders how strong the approval prospects are.

Given Global Crossing, IMCL and even ELN SEC woes, I really doubt that Amevive will sail thru.

The absolute difference between placebo and Amevive was in favor of alefacept..."But the question is how meaningful this is."" P 122

We have all been told that depletion of T-Cells is what makes Amevive work, but the correlation supporting this is weak.

I am long Xoma. My view has nothing to do with that and in fact if the same points were raised about any drug I had an interest in I would not be a happy camper.
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