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Biotech / Medical : CEPH
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To: bysfbay who wrote (482)11/4/1997 9:01:00 PM
From: WeirdPro Randy   of 998
 
<<Over two months ago, an FDA advisory board recommended (to the FDA
approval board by majority vote) not to give CEPH approval of
Myotrophin. >>

Besides the fact that the advisory panel never voted for or against the approval of myotrophin, which means the FDA would not have to go against a panel decision to approve myotrophin, Cephalon has since provided new and improved evidence from patients in the T-Ind study. In addition, the FDA is under intense pressure and scrutiny from Congress at this time for which disapproval would be met with severe repercussions.
There is sufficient information to warrant the NDA approval, as well as ethical and political reasons.
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