PGS:
1. It would be interesting to hear your description of the biologic method of action to explain how 2 trials that fixed doses to 3 in the first month of a trial followed for 3 years on the basis of Ph1/Ph2 T cell proliferation data measured in the first few months, which ultimately ultimately was not stat significant for survival, now depends on patient specific CD54 upregulation measured ex vivo before infusion on an individual dose related basis as opposed to the Cumulative CD54 upregulation vs. Survival that DNDN has actually plotted, rules out the simple expedient of increasing the number of doses over time to increase the cumulative treatment effect in terms of numbers of antigen primed CD8 effector T cells and their resulting in vivo persistence.
2. Drs. Urdal and Provost reported that Cumulative CD54 Upregulation was stsistically significant for increasing survival with a Kaplan Meier log rank p value of 0.01, the same p value as the 9901 trial, which increased to the p value of 0.002 when deaths were limited to AIPC specific mortality, and when the 225 patients in the integrated 9901/9902a database were analyzed using a Cox regresion analysis, the p value dropped further to 0.006. Please explain how and why you would further modify the 9902b trial to satisfy your statistical curiousity, while many AIPC patients would have shortened lives while awaiting its outcome.
3. My reference to "profound truth" was, indeed, a spoof, but if you have some of the real stuff, please enlighten us.
Good luck to all DNDN longs.
b
