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Biotech / Medical : CEPH -- Ignore unavailable to you. Want to Upgrade?


To: KurtVedder who wrote (593)3/10/1998 5:24:00 PM
From: limit  Respond to of 998
 
Thanks for the info Kurt. Good movement on good volume
today and the price held at the close.



To: KurtVedder who wrote (593)3/10/1998 7:08:00 PM
From: NCKEV  Respond to of 998
 
your awsum Kurt, thanks for the info..



To: KurtVedder who wrote (593)3/16/1998 4:25:00 PM
From: Rudy Saucillo  Read Replies (1) | Respond to of 998
 
This week's BioCentury has an article entitled, "Myotrophin: What's different this time?" In addition to the changes in membership of the AC, they cite new data provided to the FDA. This new data includes follow-up data from the 2 pivotal trials and analyses of pharmacokinetic and pharmacodynamic data. See also BioCentury Extra, Nov. 12, 1997.

I haven't seen any documented reference to the T-IND data, but if the company says it's part of the amended NDA package, we'll hold them to it. IMO, new data outside of the 2 trials and the PK/PD analyses are *both* necessary to convince the AC of Myo efficacy.

Rudy