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In the CY 2025 PFS proposed rule, we proposed to maintain the data completeness criteria threshold of at least 75 percent for 2 additional years

Variability in mucociliary clearance speed and mucus thickness, often affected by patient conditions such as anatomical differences, inflammation or allergies, and even the technique of administration (angle of spray, depth of insertion) (Riese et al., 2014), can alter drug absorption and uptake into the brain

Moreover, recent experimental results show that two more histidine residues located in the C terminal region of PrP provide protection against neurotoxicity, when this is exerted from the N terminal region (Schilling et al., 2020)

Subcutaneous administration is standard for BPC-157 in this context, while KPV can be administered orally, subcutaneously, or even topically for intestinal applications