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The titration schedule looks like this: 2.5mg for weeks 1 through 4, then 5mg for weeks 5 through 8, then 7.5mg for weeks 9 through 12, then 10mg for weeks 13 through 16, and potentially 12.5mg and 15mg after that
Larger and more diverse patient cohorts are needed, lower dosages of semaglutide have to be tested, and follow-ups need to be conducted beyond 26 weeks.
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
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