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Full text: #MALO #VCTE #FIB4 CUHK Medicine To view or add a comment, sign in (NASDAQ: #DNLI) The New England Journal of Medicine has published Phase 1/2 data showing Denalis Hunter syndrome drug tividenofusp alfa (DNL310) can cut cerebrospinalfluid heparan sulfate by about 90% to normal or nearnormal levels and improve or stabilize cognition, behavior, hearing, liver size, and other clinical measures in most treated children, bolstering its case for FDA priority review and potential accelerated approval

In its briefing materials, FDA staff concluded the evidence weighed against adding BPC-157, citing limited proof of effectiveness, gaps in how the substance is chemically characterized, and unresolved questions about impurities and immune reactions

BPC-157 (Body Protection Compound-157) is a synthetic pentadecapeptide consisting of 15 amino acids, with the primary sequence: Gly-Glu-Pro-Pro-Pro-Gly-Lys-Pro-Ala-Asp-Asp-Ala-Gly-Leu-Val Derived from a highly stable, naturally occurring protein fragment isolated from gastric juice, this peptide is engineered via solid-phase synthesis for structural stability in laboratory environments

Semi-automated freeze-substitution was performed using an AFS2 device (Leica) equipped with customized aluminum sapphire disc revolvers and samples were subsequently embedded in epoxy resin according to a previously published protocol 73

Injections are indicated when there's confirmed severe deficiency, pernicious anemia (an autoimmune condition where intrinsic factor is absent), or documented malabsorption that prevents oral B12 from reaching adequate levels