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doi: 10.1016/j.celrep.2024.114552 28 MaEHBantugGGrissTCondottaSJohnsonRMSamborskaBet al

These limitations can be overcome through chemical structural modifications and pharmaceutical formulation innovations

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

10.3390/md20080483 2