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Biotech / Medical : CEPH
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To: Rohit Nanavati who wrote (213)5/9/1997 12:33:00 AM
From: John Metcalf   of 998
 
To all,

Cephalon still has the opportunity to negotiate with the FDA, and actually offered today to do a post-approval study. The problem I see is that they have tweaked FDA in a brazen and irritating way through the over-confident scheme to sell shares and buy calls, through refusal to do another study, and through presentation of re-hashing when new data had been demanded (on 6/7/96 at the same committee).

If you were an FDA reviewer, working for a salary, how motivated would you be to grant approval and immediately increase the wealth of the CEPH managers who have stock options? Wouldn't any reviewer want to make them jump through all the usual hoops and clearly demonstrate efficacy before handing them the gold?

With patient advocates working for approval, this may still be a negotiable situation, if Cephalon's management doesn't succumb to arrogance.
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