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Age-dependent decline of steady state dopamine storage capacity of human brain: an FDOPA PET study

FDA staff's own briefing document, posted publicly ahead of the meeting as part of the docket, proposes that TB-500 (free base) and TB-500 acetate not be added to the list, citing incomplete physicochemical characterization, a lack of evidence of effectiveness for wound healing (including an in-vitro fibroblast study in which TB-500 reportedly did not induce wound healing), and insufficient nonclinical and clinical safety data

This dose, however, comes with serious side effects including anxiety, irritability, palpitations, acne, rash, sore muscles, achy joints, insomnia, nausea, headaches, and migraines

This is further supported by the finding that ganglionic satellite cells can differentiate into Schwann cells (Sundaram et al., 2021)

Kobayakawa et al., 2003)