LessIsMore,
Since you keep bringing this up about patients living longer not helping this trial, I will keep bringing up the fact that DC treatment is known to benefit mesenchymal type patients the most and up to 50% of a GBM patient group might start off as mesenchymal genotype. At progression (when crossover occurs) up to 85% express mesenchymal phenotytype. This is also when off site tumor cell clusters might begin to develop which is what the mesenchymal type is known to activate. If crossover patients are being treated early enough they may receive some benefit from treatment from control of off site clusters as well as in the original tumor bed. In some cases that benefit may be quite significant especially if surgery can reduce recurrent tumor size by a substantial amount or recurrence is caught very early. When both arms of the trial are receiving benefit it certainly does not help the trial end early from proving a difference in benefit between arms. When you don't expect a substantial benefit to occur in recurrent patients and then it happens, is the treatment working better than expected or worse than expected? If you answer that question honestly, as FDA needs to, then the answer is really quite clear and FDA's next steps are too which is one reason why their protocols had to change. This is why Dr. Linda Liau said there should be a path towards approval possible even though the results in the "all patients", ie crossover too, group have made the trial as set up take longer to decipher with statistical significance. General observations probably made efficacy conclusions obvious a long time ago but general observations do not fit into the rigid protocols of the process. In this case the old scientific process got in the way of declaring the obvious when the unexpected occurred. Too bad that those who are not invested couldn't or didn't want to understand this or help others to understand this. Truly sad when the process stifles innovation and keeps people suffering and dying for no reason other than their own personal agendas and egos. Best wishes.
