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Biotech / Medical : Depotech(depo)
DEPO 7.300+1.7%Aug 14 5:00 PM EST
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To: Dr. John M. de Castro who wrote (727)2/17/1998 12:22:00 PM
From: Czechsinthemail  Read Replies (1) of 887
 
John,

What is your take on the arachnoiditis side effects? It seemed to me that, along with the two different ways of viewing DEPO's clinical results, was the big surprise at the Dec ODAC meeting. My thought was that this negative side effect was an important consideration for ODAC in not simply accepting equivalency with methotrexate. I'm wondering if that is likely to be a serious enough concern that it will stand in the way of an FDA approval or that it might at least require further clinicals.

Do you know if the Phase IV trials have been set up to treat this side effect differently so that DEPO could demonstrate an effective way of mitigating it?

Thanks,
Baird
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