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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
1 The observed beneficial effects were obtained within the specifically overstimulated or damaged dopaminergic, serotoninergic, GABAergic and opioid systems
Previous reports that megadoses of vitamin C destroy vitamin B 12 have not been supported (147) and may have been an artifact of the assay used to measure vitamin B 12 status (21)
Intended for laboratory research use only
