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Monday, June 01, 2015 11:49:19 AM
http://www.nwbio.com/NWBT_ASCO_2015_5-30-15.pdf
This is potentially the most compelling data in support of the efficacy of DCVax that has ever been released in the history of the company, because it may show a treatment effect versus a control group. You know, the control group that we have been dreaming of and yearning for and lamenting that we don't have yet?? Well, we may have one here, so we should be focusing on this!! Other than Anhe, Senti, and Foxhound, (and just now dwiggd, I see) I'm not sure people here are appreciating the potential value of the Slide 10 data.
We should be discussing what we know about when and why DC Activation Method A was used versus Method B. The most important question is, was there any selection bias present such that the GROUP who received Method B had more favorable prognostic criteria PRIOR TO receiving treatment (with Method B) as compared to the GROUP who received Method A? Pyrrh is conjecturing that they as a GROUP were healthier by virtue of having entered the study after the inclusion criteria was altered to require better life expectancy and lymphocyte counts. (Note that this claim makes a number of assumptions that are simply empirical, methodological questions to figure out...was the criteria actually changed? when was it changed? If it was changed, is it possible that the criteria change happened to coincide with the change from Method A to Method B?) We should be laying this all bare in this forum. I saw on another forum a claim that the clinical trials gov site shows all modification and disputes whether this change in inclusion criteria even occurred. Lets figure out the truth. (Where is RK when we need her?!) We should be evaluating these and any other potential confounds that would render Group A invalid as a control for Group B on slide 10. Because if there was no source of selection bias between Group A and B, and thus no confounding variables, then this is extremely compelling evidence that DCVax (with Method B) WORKS, perhaps the strongest efficacy data we have had to date.
Not to mention, if Method A had some benefit but just not as much as Method B, then the statistically significant (p = .035) survival benefit of Method B over Method A becomes an even more powerful signal of efficacy.
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