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

To: squetch who wrote (18864)	4/8/1998 12:03:00 AM
From: Henry Niman	Read Replies (1) \| Respond to of 32384

Stan, Phase II trials are designed to determine the most appropriate concentration, which is then used in an expanded Phase III trial. Although the trial generally tries to determine the maximum tolerable dose, it usually falls into the mild or moderate side effect range. They really are not looking for dosages that will generate severe side effects. Remember that the trials are on patients and there is a good chance that most will not repond (remember that when 43% respond, then 57% do not respond). These are not toxicity studies designed to determine LD50's (dose at which 1/2 of the treated animals die). The FDA has a no harm no foul policy, so companies try to error and the side of safety ( a safe drug with weak efficacy has a better chance of approval than a dangeous drug with more efficacy).