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For documentation of usage parameters and a copy of the corresponding local cover article a57775, see Local Cover article

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

Psychiatry 55 , 501511

The hypoglycemia risk comes from the older medicines it sits alongside, which is why insulin and sulfonylurea doses are usually reduced first