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Biotech / Medical : Biotech Valuation
CRSP 50.19+1.8%Nov 21 9:30 AM EST
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To: scaram(o)uche who wrote (23348)3/29/2007 2:29:22 PM
From: zeta1961  Read Replies (1) of 52153
 
Your welcome Rick..the last 2 comments by panel members just said that if one looks at all the P1/P2s to-date, one cannot find a single immunologic marker that would correlate to vaccine potency?..DNDN used CD54 levels as the primary to judge it in manufacturing but DNDN rep just explicitly said that indeed the only 'proof' they have of potency is the 4 month added survival.

Edit: they just finished this discussion saying that not enuff immunology is known so the discussion essentially academic and instructive for future trials but the persuasiveness of the survival data is where they'll focus..

I also learned that the immunology data is serum based and not tumor based..

Imo, immunotherapy is an excellent candidate for adaptive designed trials..too much knowledge accumulated between initial trial design and efficacy time point evaluations..
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