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These protocols should complement rather than replace appropriate medical evaluation and physical therapy

Drug Discov

9 However, this class of drug is associated with a high risk of cognitive impairment and delirium

Studies on Epithalon and its long-term effects on aging biomarkers and cellular health consistently treat the off-cycle period as a functional part of the protocol, not dead time

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