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Biotech / Medical : CEPH
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To: arnie h who wrote (767)5/14/1998 1:21:00 PM
From: Rudy Saucillo  Read Replies (2) of 998
 
I don't understand this "last minute" comment. The FDA informed CEPH 2 years ago (June 1996) at the first Myo panel that additional efficacy data was necessary for approval. Use of the approved T-IND program to collect this data was recommended.

At the second Myo panel last year (May 1997) CEPH did not provide this data. They presented what was considered irrelevant preclinical data and surprisingly inadequate pharmacokinetic/pharmacodynamic analyses.
CEPH was again told to provide confirming data.

Then CEPH withdrew and resubmitted an amended NDA at the FDA's request (1) to avoid a flat-out rejection and (2) to buy CEPH more time to collect efficacy data.

The third Myo panel was recently cancelled by the FDA simply to avoid a third debacle given that this efficacy data still hasn't been provided.

The FDA letter simply repeats the same story...provide efficacy data and MYO will be approved. There's no "last minute" decision.

Rudy
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