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

To: Cary S. Kart who wrote (640)	4/8/1998 1:41:00 PM
From: arnie h	Read Replies (2) \| Respond to of 998

I had understood CEPH already has gotten an approvable letter on Provigil; so it should only be a few more months before approval. Also, they just announced they are starting to market Provigil in England. The attention deficit potential may not be in the price at this point. On Myotrophin, it might be worthwhile to review the bidding. Late last year, just before the FDA was to decide, CEPH withdrew the application and resubmitted. This started the clock over. Reading between the lines at the time, it seemed the FDA advised them to do this. Then in December and January, both Cephalon and Chiron went forth with public remarks anticipating near term approval. It is hard to believe, albeit possible, that they did not have some guidance to go on. Then, an advisory panel was put together and the date of Apr. 9 was subsequently announced. Now, after all this time and delays, the meeting is cancelled so the FDA can study the application further. The choices seem to be that FDA wants to disapprove and found the Advisory Panel was leaning for it, that FDA wants to approve and found the Panel was leaning against it, or that FDA is as amateurish as this whole episode seems to imply and needs more time. I'm with the camp that says the FDA will approve something as it seems they would have let the Advisory Panel do the dirty work otherwise. This seems the most consistent with the maneuvers and comments late '97.