A Noble Metal Substitution Leads to B12 Antimetabolites
It is derived from a protein found naturally in human gastric juice
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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
folic acidFolic acid, folate, vitamin B9 is used for the treatment of folate deficiency and its complications, and for the treatment of folic acid deficiency associated with liver disease, kidney dialysis,