Principal investigators in all trials are supposed to point out strengths and shortcomings within their trials; but you, a layman, spend your noninvested days criticizing this trial. For a decade.
No, I was referring to your conspiracy theory about the choice to pursue the MAA before a BLA with the FDA, and I think you’re taking her comment out of context as if it reflects the sum and total of her perspective — I believe she also said that the FDA required the crossover, that the FDA is becoming more open to ECA data, and that nothing would ever be approved for GBM if RTC design were required in all trials (suggesting that placebo participants must have access to the best available therapy).
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