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Biotech / Medical : Neuroscience

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To: Biotech Jim who wrote (245)	1/5/2003 2:32:27 PM
From: John Metcalf	Read Replies (1) of 278

biz.yahoo.com Some numbers: The Phase II study was 213 patients -- 68 @3mg/kg, 74 @6mg/kg, and 71 placebo. All were presumably evaluable. Elan and Biogen also announced that two phase III trials are fully enrolled, with about ten times as many patients. AFFIRM is a two-year study of 900 patients, and SENTINEL is a two-year study of 1200 patients. In SENTINEL, Antegren will be used in combination with Avonex. This study size is apparently what the companies think will demonstrate significant differences, if any. It should be obvious that a larger sample size is needed to determine prescribed dosage. AFFIRM and SENTINEL may determine whether identical 19% rates of relapse and close (.7 and 1.1) numbers of gadolinium-enhancing lesions differ significantly.

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