Further unified studies are required that directly compare the molecular signatures of matched tissue samples from the IVD and facet joint using clinical samples and/or mouse models of disease progression
mBio 13 , e0225122 (2022)
The FDA's concerns cite peptide manufacturing risks: incompletely characterised active ingredient, peptide fragments, degradation products, and impurities that the immune system may recognise as foreign
The typical use case is with: knee, hip, shoulder, rotator cuff, and low back issues (source)
During the open public hearing before the vote, FDA's Russell Wesdyk raised a pointed question that encapsulated the agency staff position: "What is BPC-157?" noting that the FDA had encountered multiple substances all marketed as "BPC-157" with different active molecules, and that inconsistent naming conventions alone were sufficient to prevent adequate safety and effectiveness assessment
After reconstitution with a suitable diluent, the peptide can be measured more accurately