So last decade protests!; ). PFS failure due to treatment response is not true PFS so the measures or endpoints had to be changed because no measure for PFS has proven to be sufficient to accurately measure it and the regular rules and especially exceptions to adequate and well controlled trials allowed for this. OS was confounded by treatment effect in crossover patients who were obviously living longer than expected AND confirmed earlier research that suggested DC treatment enhances other salvage therapy attempts. I have been pointing to this earlier research since beginning to post on ihub. I think FDA is very well aware of this and perhaps even anticipated this. That might be another unspoken reason why the crossover was required by them. Go figure!; ).
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