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Re: Bob_LobLaw post# 427275

Friday, 12/17/2021 8:11:35 AM

Friday, December 17, 2021 8:11:35 AM

Post# of 818507
Yes, I think changing to the more difficult gold standard of endpoints being controversial or causing a problem at FDA seems unlikely to me as well. They just did a review if early access and approved treatments conditionally based on PFS that ultimately had no OS benefit. That is because they wanted to see an OS benefit, they ended up not canceling a lot of approvals because they thought the PFS standard still allowed for improvement in quality of life, but that was not the FDA’s preferred outcome. The preferred outcome would have been extended OS or survival.
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