CEPH Message Board - Msg: 3728283

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Biotech / Medical : CEPH

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To: KurtVedder who wrote (593)	3/16/1998 4:25:00 PM
From: Rudy Saucillo	Read Replies (1) 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

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