HyGro,
You do realize, don’t you, that your complaint of double dosing (your term) is actually a confession of positive treatment effect?; ). You do realize that FDA created this situation by insisting on a crossover right? So why would FDA, creating a situation where “double dosing” (your term) was possible and might create an additional treatment effect, blame NWBO for inadequate trial design when they might otherwise take some credit for helping patients achieve better results in this trial? No blaming is going to happen as this trial was kept from enrolling all SOC/placebo patients thus under powering the trial which is why regulators had to agree to ECAs and real world evidence and real world data guidance came along side in support of contemporaneous external controls.
This trial was screened to help limit the number of original pseudoprogressors from chemo/rad who normally do better. The issue of treatment induced pseudoprogression (sign of hot tumor) became an issue with this trial anyway AND is linked to longer lived patients. This makes the crux of your argument a complaint against the treatment actually working. The other argument to be had against your claim is that wait time was up to 3 months to determine true progression or
pseudoprogression once progression was suspected which of course was not beneficial to patients because the optimum time for L to be administered is during that pseudoprogression period. Best wishes.
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