CEPH Message Board - Msg: 2484726

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Biotech / Medical : CEPH

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To: Jeffers Hughes who wrote (469)	10/18/1997 6:56:00 PM
From: WeirdPro Randy	of 998

Jeffers, the vote you are referring to was actually 6-3.....but a recap of the advisory meeting was a unanimous vote that we had one phaseIII which showed significance, and the 6-3 vote was regarding a somewhat ambiguous question of whether the "significant study" was adequate to discount the "non-significant study"....the tenor of the meeting at that time was based on a strong FDA bias, at least as discussed during opening comments, of the desire to have two positive studies to back up your NDA. Esp. for this type of disease situation, the FDA and Congress are now reducing the precedent for the necessity of two separate trials. The crucial question of whether myotrophin should be approved for marketing was never asked. As you state, "We would have been made even if there had been another vote for yes."......There is conjecture that if there had been this additional question, the results of this panel meeting might have been totally different (Indeed at least one of the "no" votes of the "6-3 vote" would have been "yes", as this panel member stated afterwards she would have voted yes to this question had it been asked).

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