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Thursday, April 28, 2022 8:20:13 PM
They can split the alpha between secondary endpoints instead, and I believe it was flipper or Doc that described a third alternative which I did not fully comprehend. As well, the final decision maker himself, Dr. Pazdur was quoted saying that P values themselves should not trump what is in the best interest of patients. I transcribed this for you earlier, but in case you missed it.
Dr.Richard Pazdur, Head of Oncology Center of Excellence - FDA 17:57
“Really, we don’t work for the regulations. We work for the US Govt and the US Govt are the patients, they are the community. And we have to always remember that we are not the American Statistical Association making decisions based on a P value. We have to weigh the risks and benefits of every application and every decision about what is in the best interest of the patients. And I always tell our staff that that should be our ultimate decision here. Is what is in the best interest of the patient in making a regulatory decision.
And if you keep that in mind, you will always be on the right side of history.”
https://collaboration.fda.gov/pbq6126oijaa/
I know that I am on the right side of history here. The question to ask yourselves is are you?
Thanks for the video ATL!
BTW - Pazdur hails from Chicago. A fitting place to make history
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=168656657
So once again, you are twisting truth to make an erroneous point. And, as I have come to expect, you will likely not reply because I make complete sense.
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