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Biotech / Medical : Biotransplant(BTRN)
BTRN 35.57-0.8%Nov 3 4:00 PM EST
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To: scaram(o)uche who wrote (1323)5/15/2002 8:57:13 AM
From: Arthur Radley  Read Replies (2) of 1475
 
Rick,
Concerning the issue of T-cell depletion with siplizumab and the dosing regimen that MEDI has undertaken in the current trials, could you help me understand this issue as it relates to the purposed new indication for RA.

1) Would the dosing regimen necessarily be the same for psoriasis as for RA?
2) "If" they actually undertake clinical trials with this new indication, would it not be safe to assume that at least they have some anecdotal evidence that the depletion issue isn't that great?
3) Concerning the start of the retreatment studies, would it not be logical to assume that MEDI had to provide some data to the FDA for them to approve such retreatments and if so, wouldn't an issue of depletion preclude such retreatments? Or, would the initial protocol agreement with the FDA allow for retreatments, without any updated data?

As always...thanks for your input. And thanks for the congrats on my daughter!
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