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Overcoming the Shortcomings of Peptide-Based Therapeutics

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

Some leave with a different plan entirely

To treat them, you'll probably need shots of vitamin B12 at first, and then you may need to keep getting shots, or taking high doses of a supplement by mouth or nasally