Personally, I think you need to read the entire article again, and each time you come across words like formally, primary and pivotal, stop and think why this trial is going to set a different precedent when the results come out. When they talk about selecting the data source and completeness therein, BEFORE completing the SAP, think about what that means.
The prior example real world trials the FDA provided were a loose amalgamation dancing around the periphery, and coming short of a primary endpoint ECA comparison in a pivotal trial.
NWBO stepped all this up to the Masters level by applying ECA control to a primary endpoint in a pivotal trial.
It is ridiculous, to the nth degree to think they would scramble for ECA comparisons after data lock, imo, but you are entitled to your opinion.
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