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Re: dennisdave post# 770276

Wednesday, 06/04/2025 9:59:38 AM

Wednesday, June 04, 2025 9:59:38 AM

Post# of 828438
dennisdave,

Because what you describe is a typical cover move it certainly reaches high up into being a likely possibility. I believe May 10th 2022 was a similar catch 22 scenario where FDA guidance had not been changed in time to allow a change on the clinical trials site to OS from PFS without announcing the change and statistical analysis plan to peers first as part of garnering peer support for the change. This is actually the process necessary for following the exceptions to adequate and well controlled studies which requires an acceptance by peers of the need for the change and adoption of the new methods utilized to adequately and properly measure treatment effect. Best wishes.
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