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

To: Greta Mc who wrote (769)	5/14/1998 9:24:00 PM
From: scaram(o)uche	Read Replies (1) \| Respond to of 998

Greta: Sincere sympathies. My major professor, a second father in my eyes, died of ALS. I was alone with him when he had his first seizure. He was a man's strong man, in every meaning of the phrase. A cruel disease. Why do you label Myotrophin as "drug" rather than as "molecule"? Preconception? Data? There's no shame in FDA's camp, Greta. None. They are trying to display scientific integrity and do an unpleasant job that needs doing. Further, they have not rejected the molecule. An INDEPENDENT advisory committee, comprised of experts, determined that the data was not sufficient for approval. It would seem, with "conditionally approvable", that FDA is walking a middle course. I'm not going to participate further in this discussion. On occasion, I feel like being supportive of a regulatory agency that seems, to me, to be doing a decent job. Rick

To: Greta Mc who wrote (769)	5/15/1998 11:40:00 PM
From: Mounir Abouzakhm	Read Replies (2) \| Respond to of 998

Greta, please accept my deepest sympathy. I would blame Ceph's CEO, not the FDA, for your tragedy. The fellow knew what was required and did not give a damn. Do not tell me that the FDA needed three years to analyze the data presented in 1995 or 1996! The fact that it took that long indicates that the FDA was waiting for additional data. The FDA does not consist of a bunch of idiots; they have some of the best educated people in the business. If they requested additional data, it means that they NEEDED these data and, most likely, the data can be obtained. Unfortunately, Ceph is managed by a blind arrogant fellow who does not give a damn about the share holders, not to mention, human lifes. Think of how many lifes could have been saved, or lived longer, if Dr. (whatever his name) accepted the FDA recommendations and started working sincerely with them. Obviously, our beloved CEO does not see it this way. It should be his way or no way. I am surprised that the board of directors, if there is any, let him do what he is doing. I think one way to expedite the drug's approval is for the CEO to leave (or be forced to leave). I hope this will happen soon, before he ruins the company completely. I believe that somebody with his mentality should not occupy such position. Again deepest sympathy and God Bless you. Mounir