K-
It was posted and read (by me) years ago. So: what would you like to say / suggest with it?
A lot of report / article dealings with the "danger" of early stop, but none of them said that early stop isn't possible ... The Co. guidance is very clear: ALL endpoints should be overwhelming, statistically significant, robust, etc.
So again: what would you like to say / suggest with this citation?
Best,
G
ps.: you forgot to admit that you were way off with pt years ...