CEPH Message Board - Msg: 1390709

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Biotech / Medical : CEPH

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To: WeirdPro Randy who wrote (288)	5/12/1997 11:20:00 PM
From: IN_GOD_I_TRUST	of 998

What I got from the committee is that it will not recommend it to be approved based on the data provided in the studies. That's it! They are not the final say. They did not say to trash the drug totally. For all intensive purposes the drug may still be approved, although historically when a commitee rules this way it usually does not favor approval. As for my questions .... 1. Is drug in a better or worse standing than before panel? Simple....worse! 2. What is the next drug and when will it even get approval? Modafinil. Probably late to early next year. It's at least 6 months away and until then how do they fill Myo gap lost revenues? 3. Did CEPH invest in there own approval and get burned, as of now? YES! 4. Is drugs CEPH working have great market? (Please do not take this as insensitive to ALS patients. I hope from a humanitarian standpoint this drug does get approved!) Limited market on next one as well, initial usage for narcolepsy. 5. How is the near term cash picture now that Myo now is looked on infavorably by panel? Did Myo committee vote against help it? All revenues included in CEPH earnings are in major jeopardy if Myo is included. Now its your turn ... Steve

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