That is incorrect. I posted the guidance many times in response to your Tweets (miss you on Twitter btw) and we don’t need to review all that again at this point.
Endpoints do need to be approved and they were. Smaller details do not require approval, but endpoints are not small. Additionally, the SAP that was used was approved and the original protocol from years ago was and is still published and is included in the JAMA supplements.
Honestly, I can’t make heads or tails of what you’re talking about most of the time. It’s almost as though your comments are coming out of some time warp. It’s 2023 and there have been significant and meaningful developments over time.