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Biotech / Medical : IMNR - Immune Response
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To: Nagaraju R. Arakotaram who wrote ()3/31/1998 2:37:00 PM
From: betthepharm  Read Replies (2) of 1510
 
Assuming the data is there, I wouldn't be shocked to see REMUNE recommended for early approval in May by the FDA Advisory Committee. To quote from the latest issue of Scrip, "For accelerated approval, a drug must offer a therapeutic gain over existing treatments for serious or life-threatening illness." Clinical endpoints are not an issue, since the FDA has bought into the use of surrogate markers. By all accounts, the markers IMNR has targeteed are responding well to REMUNE. The key question will be does the FDA buy into the use of these markers? If they don't, then REMUNE faces a long and maybe impossible road ahead. In contrast, and so far the FDA has appeared satisfied with REMUNE's progress, if they do, then there should be little reason for the FDA not to recommend for early approval. This would certainly not be an exception in this category of therapy.
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