No, that was given the original trial structure. Causes were 1) 90% of patients crossing over and loss of placebo arm due to literally perception of success; and 2) pseudoprogression which made progression (PFS) useless as a measure. But since this was able to be addressed prior to unblinding, by the filing of the SAP, and also by updated policy of the regulators, through the use of an external control arm (ECA), they applied and were approved to update the trial in these ways.
Your repeatedly quoting the risk factors as if they are anything other than a worst case laying out of anything that could go wrong for legal purposes and your misunderstanding of the trial, which you also have repeated over and over again, are misleading and false.
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