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Biotech / Medical : IDPH--Positive preliminary results for pivotal trial of ID
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To: Roger Cranwill who wrote (1074)6/27/1997 12:23:00 PM
From: Roudy   of 1762
 
Here is something I found interesting today. There were two Phase II clinicals done. One with 40 patients and another following with 120 patients. The CD4 depression was noted in a small percentage in these studies, but not enought to stop progression to Phase III. One difference between Phase II and III was the manufacturing process in the Phase III was done in a commercial type process and may have had an effect on the CD4 depression. However, the Phase III study was never unblinded. It was just discovered that there was increased CD4 depression. So, here is the question that noone else may ask. Could it have been the placebo that had the CD4 depression? Not likely, but interesting anyway. Don
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