Time of survival compared to expected outcome without treatment.
Slowing, halting, or reversing progression of disease (not necessarily complete cure).
(This is why trials can take a long time, and why the longer it takes the better the results may be.)
When the statistical analysis says so.
Beats me . . Probably many people involved including those who designed and are running the trial, the Scientific Advisory Board, and of course the leadership team.
Why IMU is a multi multi bagger, page-23
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