Monday, March 05, 2018 10:53:22 AM
The only comment I have is on your discussion of NWBO waiting longer. In your examples the p value doesn't change the longer you wait, however, the difference in your examples and the P3 trial is that the p value will not be calculated on SOC data, it will be calculated comparing the 331 patients, meaning the SOC data will be the 110 placebo patients vs ~221 vaccinated patients. You recalculate the p value using your assumed results and 110 SOC patients, and the p value falls down dramatically.
Moreover, because it is a cross over, if DCVax-L actually does work, then the 110 patients will perform better than SOC, meaning that will drop the p value even further, SO, it goes without saying (if you are well versed in Statistics), that in this case, the longer the data is matured, the more chance the p-value will drop, meaning the fatter and longer the tail of the 221 patients compared to the 110 patients, the smaller the p value will be.
Hence, why Linda and NWBO is pushing this as long as possible.
I my mind, I have no doubt the PFS endpoint has been met, and is statistically significant, however the OS endpoint may not be as strong statistically if the patients that crossed over are living longer as well.
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