I wasn't an investor back at the time of the halt, I think that was 2015, believe it or not, that's when PFS was abandoned as a goal with the concurrence of the regulators. Coming out of that halt it was clear the control group was abandoned and so was PFS, everyone knew of pseudoprogression back then and they agreed to change the trial protocol. Nothing required these changes to immediately be made in clinical trials, or anywhere else, nor did an SAP need to be agreed on immediately, it only had to be done before the trial was locked and the data collected.
I don't doubt that things like getting all four regulators to agree on things like the SAP may have taken much longer than people believed it would, but again the only deadline was do it before the trial was locked. I suspect that the company and the regulators may have agreed that 5 years of data for even the last patient to enter the trials was desirable, but only they can say if it was agreed on, or if the company determined to take it that far, or further to get a specific number of events.
You can keep repeating your opinion that these changes were made after they knew the data, it's clear this isn't the case, the decisions were made back when things changed during the halt. The trial resumed with all receiving the vaccine and pseudoprogression clearly determined to have falsely been thought to be progression.
Believe what you will but you cannot deny the changes made after the halt and those changes all support how the trial was ultimately documented when the documentation was changed, and all that needed to be changed before the trial was locked up had been changed.
Gary
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