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Biotech / Medical : CEPH
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To: squetch who wrote (603)3/15/1998 3:03:00 PM
From: Rudy Saucillo   of 998
 
Study #1200 (US study) consisted of 266 patients in 3 treatment groups: placebo, low dose Myo, and high dose Myo.

Study #1202 (Euro study) consisted of 183 patients which were 2 to 1 randomized placebo to high dose Myo. Treatment periods were 9 months long for both studies.

I'm not sure how CEPH implemented their data collection in the T-IND program. The FDA AC comments about using the T-IND program to obtain additional efficacy data where made after CEPH had initiated the program. Did CEPH expand their IND program and include some sort of randomization process???

Rudy
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