Alpha, under the assumptions you make I think your argument is strong. However, there is the elephant in the room which you do not address in any way. Why did the company decide to significantly prolong the study to test for OS and even more significantly, an OS long tail? If PFS is so obviously significant wouldn’t they have stopped the trial as designed initially? To extend this trial by 3 years in spite of such a success in the primary end point seems crazy in the world we live in today where these small companies are starved for funding desperately needed to survive from day to day, let alone for 3 years!
Enter the pseudoprogression hypothesis with a resulting failed PFS.
Thoughts?
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