CEPH Message Board - Msg: 1411413

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Biotech / Medical : CEPH

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To: harkenman who wrote (320)	5/15/1997 2:14:00 PM
From: Rudy Saucillo	of 998

Harkenman, this is a very good question for discussion. CEPH submitted data from the U.S. trial and the European trial as part of their market approval application in Europe. This is the only Phase III data they currently have. I have heard opinions that since there is no compassionate use program in Europe, pressure will be very high for approval. Regardless, speculation on what the FDA and European regulatory agency will decide re Myo approval is just that....speculation. I believe Myo has a chance in both regions because of the demand and because of the safety profile (which is not in question). But I don't mean to imply it's a sure thing. My point throughout our discussion is that CEPH faced a setback at the Myo panel, but the story continues. Rudy

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