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It does not mean the products are safe, pure, or accurately labeled

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

Unlike traditional anti-inflammatories that only reduce pain, TB500 may actually stimulate repair in connective tissues

Sample size calculation Based on BinShuwaish et al

Rheumatoid arthritis: advances in treatment strategies