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Posted On: 10/25/2020 3:01:09 AM
Post# of 148908
DaveEL,
You bring up a good point. I don't know the answer.
We all sincerely hope that the 75% interim represents an opportunity for a trial halt.
If that's not their agenda, it may be the DMSC's way to peek at the new Mortality at Day 42 results to make absolutely certain that new endpoint is going to have a 'happy ending' at 390.
If it's a strong signal at 75% interim, maybe they tell CytoDyn to continue to 390. If it still need to be fortified with a higher N=, maybe they advise CytoDyn to go beyond 390.
However, if the DSMC (who is paid by CytoDyn) does not take a peek at the new Day 42 number at 75% interim, then CytoDyn blindly pulls into the 390 finish line without really knowing how the race going to end.
So, from that standpoint, the 75% interim might be more of an insurance policy that ensures the success of a slightly longer trial.
But again, I don't' know.
You bring up a good point. I don't know the answer.
We all sincerely hope that the 75% interim represents an opportunity for a trial halt.
If that's not their agenda, it may be the DMSC's way to peek at the new Mortality at Day 42 results to make absolutely certain that new endpoint is going to have a 'happy ending' at 390.
If it's a strong signal at 75% interim, maybe they tell CytoDyn to continue to 390. If it still need to be fortified with a higher N=, maybe they advise CytoDyn to go beyond 390.
However, if the DSMC (who is paid by CytoDyn) does not take a peek at the new Day 42 number at 75% interim, then CytoDyn blindly pulls into the 390 finish line without really knowing how the race going to end.
So, from that standpoint, the 75% interim might be more of an insurance policy that ensures the success of a slightly longer trial.
But again, I don't' know.
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