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While Alnylams Phase III APOLLO-B study hit both key primary and secondary endpoints, the FDA stated in the documents that the effects of patisiran compared to placebo on both endpoints were small, of questionable clinical meaningfulness, and may not be detectable by patients. Major discussion points during the adcomm meeting included whether these key endpoints were appropriate to ascertain clinical meaningfulness in the ATTR-CM population, and panelists expressed varying opinions on whether the magnitude of the benefit seen in trial data was clinically meaningful

It appeared, as a peptide native and stable in human gastric juice, as a late outbreak of the cytoprotection/organoprotection concept of Robert and Szabo, a concept mostly from the stomach studies [10,11,12,13,14,15,16,17] for epithelial and endothelial protection, like the previous theoretical/practical breakthroughs in the 1980s and braingut axis and gutbrain axis (for review, see, i.e., [2,3,4,5,6,7,8])

Peptides are sensitive to UV degradation, so always keep the vials in a dark place, like the box they came in, even inside the refrigerator

Diet-induced endotoxemia is defined as metabolic endotoxemia

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