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

To: WeirdPro Randy who wrote (598)	3/14/1998 12:39:00 PM
From: Rudy Saucillo	Read Replies (1) \| Respond to of 998

WeirdPro, I don't have any info on the new data - I suspect it's being held fairly closely. At the last Myo panel, Leber et al. severely chastised CEPH for not providing any new relevant analyses and for not having the foresight to collect additional data through the T-IND program. As a matter of fact, after the first panel when T-IND approval was recommended, the AC told CEPH not to return without new data. Given the IND approval, the AC expected CEPH to use the IND lottery to acquire additional patient data. That is, randomize patients in two groups - placebo and high dose Myo - using the lottery process and collect data from the treating physicians. Although this is not considered nearly as rigorous a methodology as a clinical trial, a large patient population could smooth out some of the inherent variables. By being creative with this process, CEPH could have collected data supporting (hopefully) Myo efficacy. The FDA committee stated that IND drug distribution lotteries are currently being used to collect additional efficacy data for several cardiovascular drugs. At the last panel, the committee also expected detailed post-hoc analyses to show why the US study (#1200) demonstrated efficacy and the Euro study (#1202) did not. CEPH/CHIR did not present this data. The committee said it wanted a review of subgroups within the two trials to give them a "hint" that 1200 was the 'real' trial and that 1202 results may have occurred by chance. I don't know if this analyses will be part of the upcoming panel. So, I believe that if CEPH has legitimate data from the T-IND program giving even a hint of efficacy, we'll see Myo approved. Still a big question. I'm sure the FDA and the AC have no tolerance for any more BS from CEPH. Rudy