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Biotech / Medical : Ligand (LGND) Breakout!
LGND 191.75+1.0%Jan 5 3:59 PM EST
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To: Machaon who wrote (26715)12/1/1998 3:15:00 AM
From: Henry Niman   of 32384
 
Bob, Since the advisory committee met only 9 days prior to the 6 month deadline, it's not surprising that a few details remain. I'm not surprised that LGND has already submitted the chemistry detail. I suspect that the data was readily available and was submitted in response to FDA requests. As far as the labeling is concerned, I don't think that much could have been done before te meeting, because no one really knew for certain what the committee would suggest. After the meeting, it was possible to negotiate the labeling.
LGND has a sales force ready to go, so I suspect that the labeling issues will be resolved very quickly and a launch this year is very possible (although the launch this will probably be hampered by the holidays, as suggested many weeks ago by on of the analysts (Bear Stearns?).
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