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Friday, November 05, 2021 12:14:09 AM
I have mentioned a regulatory final issue. My point has absolutely nothing to do with endpoints. Nothing.
I believe the endpoints are not controversial and fully approved, by all regulatory authorities. I have explained that the FDA, will all endpoints for all companies no matter when they were proposed, at the very beginning or revised, can always reserve the right to update its view, even with an Special Protocol Assessment, which is explicitly supposed to be a way to avoid that, and even then, it’s no guarantee they won’t change their mind. I do not believe that applies here, because OS is the actual gold standard. There is not a higher measure of success.
So that’s my view in that point.
I believe the endpoints are not controversial and fully approved, by all regulatory authorities. I have explained that the FDA, will all endpoints for all companies no matter when they were proposed, at the very beginning or revised, can always reserve the right to update its view, even with an Special Protocol Assessment, which is explicitly supposed to be a way to avoid that, and even then, it’s no guarantee they won’t change their mind. I do not believe that applies here, because OS is the actual gold standard. There is not a higher measure of success.
So that’s my view in that point.
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