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As FDA states in their guidance document on the Q-Submission program, Early interaction with FDA on planned non-clinical and clinical studies and careful consideration of FDAs feedback may improve the quality of subsequent submissions, shorten total review times, and facilitate the development process for new devices. While this is not meant to be a general pre-review of your submission, it is there to help you get answers to questions directly from FDAwhich will contribute to a smooth submission and, hopefully, approval

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[2] Watanabe T, Sagisaka H, Arakawa S, Shibaya Y, Wantanabe T, Igarashi I, Tanaka K, Totsuka S, Takasaki W, and Manabe S (2003)

Relevance to Endurance Athletes The endurance rationale for TB-500 centers on three effects: angiogenesis promotion (new blood vessel formation improving tissue perfusion), inflammation modulation (calming excessive responses that delay recovery), and anti-fibrotic activity (reducing scar tissue that causes stiffness and re-injury risk)