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Biotech / Medical : Ligand (LGND) Breakout! -- Ignore unavailable to you. Want to Upgrade?


To: Machaon who wrote (22433)6/17/1998 10:46:00 PM
From: Torben Noerup Nielsen  Read Replies (2) | Respond to of 32384
 
Bob,

>Well, which is it, clarification or deficiencies?

I wonder. But I have a hard time reconciling deficiencies in the drug itself with the advisory panel vote. If it is the application per se that needs to be cleaned up a bit, then this is all trivial. It seems to me that the advisory panel was clear on the clinical benefit and the safety issues.

Does anyone know if this is unusual for a fast-track application? It seems pretty obvious that the FDA did this on the last day just to stop the clock and gain some breathing room.

Thanks, Torben

P.S. Yes, I did get back. I barely made it out of Norway before the ATC strike. I had to take a 4am flight in order to avoid a strike that started at 8am!