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Posted On: 05/23/2021 3:22:35 AM
Post# of 148902
Ohm, I agree. I have been a regulator in a sense with the federal government, as a contracting officer and as senior officer for fifteen years. I have written to the FDA. I complained about the letter being deficient in its characterization of the CD10 results on the NEWS2 secondary endpoint. I challenged their imperious prescription that trials must be well constructed but omitted that the FDA approved the trial design and was involved with rejecting a 4 dose regimen, I also objected to their hypothesis that CD12 showed no benefit. I did not argue about the EUA. As regulators they will argue p values, rules etc. but as Federal employees I argued that they have an obligation to ensure what they publish is correct and fulsome. I feel this is a weakness I have a right to hold them accountable.
And I do agree that we should treat them formally with professional courtesy.
And I do agree that we should treat them formally with professional courtesy.
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