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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: kha vu who wrote (26714)12/1/1998 12:35:00 AM
From: Machaon  Read Replies (3) of 32384
 
<< The final approval is pending review of additional chemistry information submitted by the Company as requested by the FDA and upon final labeling agreement. >>

Kha, thanks for posting the article. I hadn't picked up upon the fact that the chemistry info has already been furnished to the FDA. It sounds like it was fairly easy to come up with the data, especially since it only took a day or two. So, providing that the chemistry data satisfied the FDA request, the main issue is a labeling agreement. Hopefully the labeling won't be too restrictive.

Ligand expects approval by the end of December, so I would think that approval is almost a slam dunk at this time.

Panretin Gel approval will be delayed about one month, IMHO. Not too big a deal. But, as long as there is uncertainty hanging over the final approval, Mother Market will probably be cautious.

Regards, Bob
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