Indications -- Psoriasis/Chronic Inflammation Message Board

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Biotech / Medical : Indications -- Psoriasis/Chronic Inflammation

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To: scaram(o)uche who started this subject	9/17/2002 11:53:50 AM
From: scaram(o)uche	Read Replies (1) of 631

I don't get it. Genentech and XOMA provide conclusive data re. efficacy. But a PK study shows that material manufactured by XOMA differs from the stuff that DNA makes. So, FDA asks for another study, using material from the DNA SOPs/facility. Why 556 patients in a huge phase III trial? 556 patients!! Did anyone else understand that the trial was going to be that large? Did I simply miss something? Seems a bit of overkill.

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