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

To: Brian Pastor who wrote (480)	11/4/1997 3:30:00 PM
From: Lance	Respond to of 998

I'm sorry if I mislead you, I meant the approval of Myotrohin is expected to come from the FDA on November 11 (or before). I just hope it"s positive & keeps the momentum that we already have up! Go CEPH..... Race..

To: Brian Pastor who wrote (480)	11/4/1997 6:39:00 PM
From: bysfbay	Read Replies (2) \| Respond to of 998

> This is simply the end of the 90 day extension the FDA announced on > August 11, 1997. So it appears the money is heavily betting on > approval. Over two months ago, an FDA advisory board recommended (to the FDA approval board by majority vote) not to give CEPH approval of Myotrophin. Cited was inconclusive results from a European study where the non-control group had an elevated number of deaths over the control group. Between then and now, what would've changed other than continued good response by patients using this drug? Is this sufficient to warrant NDA approval?