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Re: rayovac812 post# 432569

Sunday, 09/24/2023 7:58:57 PM

Sunday, September 24, 2023 7:58:57 PM

Post# of 463809
I agree with your points. The question is really about how the FDA will view the biomarkers that are not recognized surrogate biomarkers.

The data presents a strong case in totality. The FDA does have some flexibility in what it chooses to consider but it does take into account precedent.

We will just have to wait and see how the FDA decides to act.

The real folly is ignoring the progress the company has made.

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