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Sikiric et al., 2010

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

Identity, HPLC purity and heavy-metals results are published below as documented on the certificate

The Shohami WDI model is a closed head injury (CHI), which is induced using a weight-drop impact on one side of the unprotected skull (Shapira et al., 1988

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