(Total Views: 429)
Posted On: 03/13/2021 7:10:08 PM
Post# of 154658
Respert24 -- when you say "approval", do you mean EUA?
It is my understanding that we can never get a full approval (that would then allow for off-label use and label expansion) without filing a BLA. I'm not sure if this is accurate.
I share Evil's concern/suspicion that CD16 will not happen. But, that should be known within a week. If we don't have an update by the end of next week, I would suspect that it will fade away. But, I'm probably 70/30 that it will launch.
My bigger concern on CD16 is that I just don't understand how 140 patients can be enough. It seems way to low. Would love one of our "math folks" to weigh in and tell us that it is fine. (Is it "risky fine", or obviously fine?)
How can 140 be enough, based on all of the other trials?
It is my understanding that we can never get a full approval (that would then allow for off-label use and label expansion) without filing a BLA. I'm not sure if this is accurate.
I share Evil's concern/suspicion that CD16 will not happen. But, that should be known within a week. If we don't have an update by the end of next week, I would suspect that it will fade away. But, I'm probably 70/30 that it will launch.
My bigger concern on CD16 is that I just don't understand how 140 patients can be enough. It seems way to low. Would love one of our "math folks" to weigh in and tell us that it is fine. (Is it "risky fine", or obviously fine?)
How can 140 be enough, based on all of the other trials?
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