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Biotech / Medical : Ligand (LGND) Breakout!
LGND 195.83-0.7%Dec 26 9:30 AM EST
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To: J Stone who wrote (26615)11/18/1998 2:12:00 PM
From: Machaon  Read Replies (1) of 32384
 
<< The comments gave me the sense that LGND management should have been more careful in what they submitted and perhaps how they submitted it. >>

Ligand had delayed the submission of the Panretin Gel KS NDA in order to include additional test results. Right now, that seems like it was a good idea.

I too was a little surprised about the debate over what the photos represented. 50% of the photos were questioned. Even so, the panel voted for approval, which means that there were significant results and patient testimony showing the effectiveness of Panretin Gel.

I did find it a little disheartening to see the negative emphasis being put on a visual interpretation of non standardized photos. I agree that Ligand seems to have dropped the ball concerning the "quality" of the photo presentation.

<< I'm not assuming that they won't get approval by year-end. I am worried that they might not. >>

I think that most of us are in the same boat. However, the odds are on our side based on the combination of the panel vote for approval, significant clinical test results and an apparently effective "topical" treatment, with acceptable side effects, for a currently non-treatable ailment.

Regards, Bob
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