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Biotech / Medical : CEPH
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To: K.Martin who wrote (171)5/8/1997 2:10:00 PM
From: WeirdPro Randy   of 998
 
I borrow from Kurt Vedder's post for a positive spin on today so far. He writes this based on exhaustive research of his own, including his reading (twice!) the minutes from last June's meeting.
<<Dr. Paul Leber is the same FDA representative who spoke at the 6/7/96 hearing. He said the exact same thing at the earlier hearing. The other 2 FDA representatives, primarily Dr. Temple, are more understanding of Myotrophin. The morning of the IND hearing June was very negative. However, in the afternoon, the Panel had to answer specific questions regarding whether or not to approve the IND based on one trial. And they did. Everything Dr.
Leber says about Myotrophin is negative and always has been. The Advisory Panel knows this. If the Panel feels a third trial is necessary, then they will recommend approval of Myotrophin as long as they agree to do a Phase IV study. The Panel is going to ask tough questions. They can't make it look too easy. >>

To paraphrase John Lennon, "You may say he's a dreamer, but he's not the only one"
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