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

To: N who wrote (12618)	12/15/1997 1:51:00 PM
From: Henry Niman	Respond to of 32384

Nancy, Details of the sort you asking about generally show up in publications, which in LGND's case have been trailing the clinicals. They have published a fair amount of pre-clinical data, but most of the clinical work is still in the rough draft or "in press" stage. The press releases have the most current info. In general, LGND's retinoids and rexinoids have many applications. Some indications come from their pre-clinical data, and some come from applications of related compounds. Retinoids are a fairly hot topic, so many publish quite a bit on them. In general, LGND does the Phase I safety studies and then does small Phase II trials to determine optimal dosage and appropriate indications. They then move into Phase III trials after extensive discussions with the FDA. For the Panretin topical, a delta of 15% was the agreed upon end point. I think that they increased the sample size (from 240 to 268) to get a respectable p value. Less than 0.05 is generally considered "significant", the FDA likes to see less than 0.01, and LGND achieved a 0.002 in their North American trial (and a much lower p value in the International trial).