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Biotech / Medical : CEPH

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To: Rohit Nanavati who wrote (165)5/8/1997 10:52:00 AM
From: Techperson   of 998
 
Bloomberg News, 9:39 AM EDT - Cephalon and FDA officials offered an agency advisory panel conflicting views of studies of Cephalon's Lou Gehrig's disease drug. While CEPH and CHIR officials said the drug can help slow the devastating effects of the disease, FDA officials said contradictory studies of the drug have left them unconvinced.
"Our view is the fact that 1202 (European study) does not corroborate the findings of 1200 (U.S. study) is very disconcerting," said Paul Leber, Director of the FDA's division of neuropharmacological drugs.
Later today the panel will be asked a series of questions, one of which is if it can "on the strength of the evidence provided in this single study (the U.S. study) and taking into account the failure of the only other completed adequate and well-controlled clinical investigation to confirm its findings, conclude that there is substantial evidence that Myotrophin is effective."
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