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This process allows for coordinated pretrial proceedings, including discovery and any potential settlement discussions, ensuring efficient handling of the case alongside others with similar allegations

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

Nature 619 , 572584 (2023)