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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

How often should I receive IM injections

The cleanest math of all three options

TB4 (from which TB-500 derives) is relevant in dermal ulcer and skin cell regeneration research

Monthly B12 Injection Protocols Many patients get monthly B12 injections