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General Handling: Use appropriate laboratory PPE and standard laboratory procedures

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

BPC 157 normalized MDA and NO-levels in the liver of BDL rats (Sever et al., 2019) and wound-healing response to chronic liver injury that may be accordingly modified (Figure 12) (Albanis and Friedman, 2001

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