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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

Mobilizing stored mycotoxins into the bloodstream poses a severe risk of transferring those toxins to the fetus across the placenta or to the infant through breast milk

If these questions linger in your mind, fret not

Instead, the parties will present arguments in support of their positions

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