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Biotech / Medical : Biotransplant(BTRN) -- Ignore unavailable to you. Want to Upgrade?


To: michael_f_murphy who wrote (1347)6/26/2002 6:41:24 PM
From: aknahow  Read Replies (1) | Respond to 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.



To: michael_f_murphy who wrote (1347)6/28/2002 9:48:34 AM
From: Arthur Radley  Read Replies (2) | Respond to of 1475
 
The CEO gave me the courtesy of a phone call this morning to respond to my concern about the new IND for RA that MEDI should be filing. He assured me that initiation of paper work has been started and that normally it takes about 30 days...so by the end of July it should be final. However, it is still up to MEDI to release the information to the public. IMO...they should.

It is gratify IMO that a CEO will take the time to respond to a shareholder's concern...not that always the new is what we want, but in this business climate we need more candor from the executives leading the companies we invest.