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Re: boi568 post# 402875

Saturday, 02/11/2023 3:51:40 PM

Saturday, February 11, 2023 3:51:40 PM

Post# of 460039
except that the proposed change to FDA guidelines disagrees with your statement:

Considerations for the Design and Conduct of Externally Controlled Trials for Drug and
Biological Products Guidance for Industry

"if the natural history of a disease is well-defined and the disease is known not to improve in the absence of an intervention or with available therapies, historical information can potentially serve as the control group"



Seems like 20,000 placebo AD patients over 20+ years is not enough data for you?
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