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Biotech / Medical : Ligand (LGND) Breakout!
LGND 197.01-2.9%Dec 1 3:59 PM EST

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To: Louis A. Rawden who wrote (27394)1/14/1999 7:49:00 AM
From: Henry Niman  Read Replies (1) of 32384
 
Louis, I think that many investors are taking a look at Biotechs, so if you have a question, you can be fairly certain that many more would also like more info.

For clinical trials, the three Phases are divided up to provide info for a NDA (New drug Application) and results from one phase are used to design the trial for the next phase.

Phase I is designed to see if the compound is safe in humans (and a fair amount of animal is a prerequisite for the start of a Phase I trial). If the compound is safe, then Phase II trials are designed to determine the optimal concentration. Phase III is designed to used the optimal concentration on a larger population.

If the data is very positive in Phase III (as it was in the International topical trial for Panretin), then the company may elect to halt the trial because they have enough data to submit in their NDA application, and it would be unethical to continue to treat patients with the inferior treatment (for Panretin the control arm received a placebo, but sometimes the control gets the gold standard).
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