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It's enough to make anyone wonder: Am I missing something

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

The translation from rat studies involves significant assumptions that may not hold

Characterized Signaling Pathways Published research has identified multiple cellular signaling interactions: Nitric Oxide Signaling (eNOS) Research by Hsieh et al