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

To: NeuroInvestment who wrote (754)	5/13/1998 11:45:00 AM
From: Rudy Saucillo	Read Replies (2) \| Respond to of 998

I agree 100% with NeuroInvestment. I believe this letter is strictly a political ploy to shift the onus on CEPH for Myo approval. The story seems to be the same...provide additional data demonstrating efficacy and Myo will be approved. Nothing new, but in our political environment appearance is everything. Cancellation of the recently scheduled Myo panel was probably part of the plan. A 3rd debacle in front of the Advisory Committee would have made the "approvable contengent upon" letter next to impossible to release. It will be interesting to see what the FDA requires for additional data. We know CEPH didn't follow the Advisory Committee's strong suggestion of using the T-IND program to collect follow-on data. The only ongoing study is the Japanese Phase III study. Results are several years(?) away. Rudy