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Biotech / Medical : CEPH
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To: The Dermatologist who wrote (330)5/15/1997 4:55:00 PM
From: Rudy Saucillo   of 998
 
Yes, in the European trial, a greater number of deaths were seen in patients on Myo than patients receiving placebo. But it was shown that these deaths were associated with previously identified risk factors including age and pulmonary function. The FDA was completely satisfied with this data prior to the IND panel last June. No one with the FDA or on the FDA advisory committee raised safety as a concern at either the IND hearing in June or at last week's NDA hearing. Efficacy of Myo is the issue in contention, *not* safety! Rudy
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