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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

Inject the medication exactly as instructed by the medication guide or care team

Diethyl ether was added to precipitate the oligomer and the solid was triturated and filtrated

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doi: 10.1016/j.heliyon.2019.e03013 342 KambojASalujaAKKumarMAtriP