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On the other hand, preclinical studies and clinical trials highlight the potent anti-inflammatory effects of TB-500 in various models of organ and tissue injury, including in the skin, eye cornea, liver, and central nervous system [34, 35, 38, 39]

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The peptide does not simply increase nitric oxide levels

It is precisely because the liver questions are the hardest and slowest to answer that the FDAs Breakthrough Therapy designation in this indication is meaningful for the development timeline, even though it changes nothing about the drugs current unapproved status