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Re: ATLnsider post# 462560

Monday, 04/25/2022 7:13:55 PM

Monday, April 25, 2022 7:13:55 PM

Post# of 700358
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
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