Monday, March 07, 2016 1:03:51 PM
I understand your concern about the psPD patients getting into the info arm and the info arm data being potentially reflective of this, however, this should be balanced out by trial design in the Phase 3. For every SOC psPD patient that potentially could be mislabeled a progressor and then get treatment, there should be 2 of the same from the treatment arm that received the more timely treatments and would be expected to event later, especially if this trend is seen more in mesenchymal GBM as per Dr. Linda Liau's comments. If the ratio of events correlates well to higher numbers of mesenchymal biomarkers and methylation as Dr. Linda Liau has alluded to then PFS benefit has a very good chance to be well established. In this scenario the only confounding data would be coming from .33 of the psPD crossover population. If Reefrad and you can agree on the scan interpretations, I believe other expert radiologists will, upon review of all the data, be able to agree as to what was actually happening and when. I also believe that the benefit will be ascribed to treatment and not separated from it. Then, when they look specifically at the mesenchymal GBM patients, the data should really stand out both with PFS and OS. Either this is true or Dr. Linda Liau is misinformed. My money is on Dr. Linda Liau being right.
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