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If the committee recommends inclusion, the FDA would still need to complete its review and rulemaking process before formally adding any of the substances to the 503A Bulks List

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Anti-inflammatory effect TB-500 reduces the expression of the pro-inflammatory cytokines TNF- and IL-1 in several preclinical models of tissue injury

doi: 10.21037/tp-21-367 35

Loading phase uses higher doses (2.5-5mg) 2x weekly for 4-6 weeks to rapidly saturate tissues and initiate healing