Sunday, January 10, 2016 2:56:42 PM
1. Liau says "it seems like everyone is living longer than expected... I guess it's a good thing the patients are living longer...but it's not really helping our study because if the patients that didn't get anything, hopefully the control..the differences would be bigger"
To me, the main point here is specifically about the placebo patients. She says "living longer", but really I think she means progressing slower because if they progressed like expected there wouldn't be any delay in reaching the events, which is what she is implying. They would progress and cross over. Receiving treatment at that point would potentially explain living longer, but it wouldn't have any impact on reaching the number of events required for completion of the study. Interesting that this scenario of slower progression in both groups matches up precisely with the scenario that Pyrr predicted caused the trial re-sizing.
This means the bar will be higher for DCVAX to show an improvement over SOC. We shouldn't forget that IMUC experienced this phenomenon in their trial which caused it to come up short of the primary end point. They speculated it was due to the placebo they used. So I am left wondering what factors are contributing to the longer PFS of the placebo patients in NWBO's trial and what impact this will have with regard to the comparison of PFS in the treatment vs. control groups? Is this information a predictor that NWBO will experience the same fate as IMUC?
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