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Biotech / Medical : XOMA. Bull or Bear?
XOMA 32.93+2.9%Nov 18 3:59 PM EST

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To: aknahow who wrote (5196)12/30/1997 10:44:00 AM
From: Edward Paule  Read Replies (2) of 17367
 
<<<P III also requires patients to be at 8 or higher on the scale for P III also. Must say I do not understand why the need to wait so long>>>

George,

The answer is simple. Kids must die in the placebo group for rBPI21 to show statistical significance. Unfortunate for them, but that's how the system works.

If rBPI21 works at this level, as the open label study seems to show; and level 8 or higher maximizes the probability of death in the placebo group; and this happens often enough so that a trial doesn't last forever; then IMO it's a sound design for a phase III trial.

- Ed.
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