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10.3748/wjg.v23.i48.8465 19 EustisS.ElwellM.MacKenzieW

Inject AOD-9604 (250500 mcg subcutaneous)

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