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Biotech / Medical : CEPH
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To: VLAD who wrote (762)5/14/1998 11:21:00 AM
From: Rudy Saucillo  Read Replies (1) 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.
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