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Re: Doc328 post# 456043

Sunday, 04/07/2024 6:57:09 PM

Sunday, April 07, 2024 6:57:09 PM

Post# of 461416
According to the FDA there is only one surrogate biomarker for AD and that is plaque reduction. There are no qualified biomarkers for AD according to the most recent list I could find on the FDA web site.

The FDA has indicated that it is willing to consider other biomarkers in NDA submissions.

If I have this right, plaque reduction wasn't considered a valid surrogate biomarker until the mab NDAs were submitted.

There are a number of biomarkers that are used in diagnosing AD. What the FDA has to say about that won't be known until they are put through the qualification process or used in an NDA submission.

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