I said the crossover was the rescue medication for recurrent disease whether treatment or placebo. The trial was designed ONLY for naive GBM patients.
It was only after they knew they had failed the primary endpoint they scrambled to redesign the trial and added the "recurrent GBM arm" from the placebo arm patients treated with the rescue. Clever, but not the original trial design. All this was designed AFTER the FDA partial trial had stopped the trial, and two weeks before the datalock.
No placebo and had to create an ECA after the trial was virtually over. FDA ECA Guidance required ECA design and analysis BEFORE the trial starts.
So much bias from "after the fact" ECA. ECA design failed to use patient level data, consultants created data from the graphs of the trial data. Unbelieveable. Then there was the dubious screeners -- NWBO required full resections, multiplte ECA trials allowed biospsies which has a much higher death rate to begin with. Now wonder 7 publications outlining the trial deficiencies and bias and the inability to produce a legitimate conclusion. And the FDA will clearly have considerable problem with the major changes and all the violations of FDA Guidance.
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