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Sunday, January 24, 2021 12:33:58 PM
The information we have for enrollment is MONTHLY, and that matters quite a bit, compared to yearly, when projecting and counting. It is only now that the trail is complete that we can entertain the yearly numbers. Earlier this is the wrong thing to do.
The end-point measure is a statistical regression at 3 year mark.
There may be a vast difference between test and control at the end of the trail, however, the primary end point is what does it look like on a kaplan meier chart at 3 year mark. The significance of this cannot be overstated.
We have to show 10% at 3 years ( according to the design anyway ). The end may be 30% difference but does it regress to 10% at 3 yr.
It is a high hurdle to jump.
Maybe today we can get away with 8%, but the design says 10%
( I think it is 11.25% )
But I also know that is very hard to do.
Recent CVM News
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