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

To: VLAD who wrote (762)	5/14/1998 5:37:00 AM
From: SnowShredder	Respond to of 998

The FDA is in a bind because they are getting a lot of pressure from the public about this drug, but you have to think that there decision on this case will set precedence for future studies. CEPH and CHIR showed blatant disregard for the FDA's recommendations...thus I would not be surprised if they denied approval. If they do approve myo then in the review committees lose credibility which will probably lead to more disrespect...the pharms will say but what about myo? and will try to get their drug approved the same way even if it has bad side effects. A bad pattern would form and the pharms would have the upper hand over the FDA. I feel for the ALS patients and hope for them that it would be approved, but I would not be surprised to see the FDA deny myo to set precedence that we are in charge...listen to our recommendations...and to keep the pharms in check. <eom> Best of Luck, Where'd He Go?

To: VLAD who wrote (762)	5/14/1998 9:02:00 AM
From: scaram(o)uche	Respond to of 998

VLAD: Given this rationale, Debler would also approve any number of placebos. I am fully in sympathy with your emotional argument. Your response and my note supportive of the FDA are typical of the volumes that have been written on this issue. Rick

To: VLAD who wrote (762)	5/14/1998 11:21:00 AM
From: Rudy Saucillo	Read Replies (1) \| Respond to of 998

VLAD, I attended both Myo panels and have seen data from the US and Euro studies. I've also seen the complete lack of response by CEPH to the AC's request for data confirming the US study results. If the differences in results could be explained as simply as you suggest, Myo would have been approved 2 years ago. The fact of the matter is that CEPH has not been able to provide post-hoc analyses to explain the lack of efficacy in the Euro study and has refused to provide additional clinical results demonstrating efficacy. The T-IND program was an excellent opportunity to gather this data. In their arrogance, CEPH botched it. I agree completely with Rick H. The FDA has an obligation to the public to approve only safe and effective drugs. Their fundamental position with CEPH hasn't changed. I sympathize with the ALS patients but I don't blame the FDA for the current situation. If CEPH had used their T-IND program to gather additional data and if this data were positive, Myo would now be an approved drug.