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The FDA stated that the accelerated approval rests on improvement in knee extensor muscle strength, an intermediate clinical endpoint, and that as a condition of approval the sponsor must conduct a post-approval randomised, double-blind, placebo-controlled trial to verify that the change in knee muscle strength translates into clinical benefit (FDA press announcement, 19 September 2025
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Figure S8: Spectrophotometric titration of Sav-HABA with BioGHK
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