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Biotech / Medical : VAXGEN INC. (VXGN)- The IPO

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To: gary r. albrecht who wrote (32)	7/11/1999 5:01:00 PM
From: GPSite	Read Replies (1) of 55

gary, It is dangerous to extrapolate data from phase I and II trials, and that's why the FDA doesn't allow it. These trials are not carried out in a double-blind fashion so there is no control and no way to evaluate the data against some standard. Statistically, one could make gross errors drawing conclusions from uncontrolled trials. That's why a phase III is done. Even though the phase I and II volunteers have done better than would be expected given the known conversion rate of the high-risk population, one cannot draw any conclusions. GPSite

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