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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

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Call your provider if: Youve had persistent side effects for more than 4 to 6 weeks with no improvement Youre struggling with daily tasks because of the symptoms Youre experiencing dehydration or cant keep food down You notice anything unusual that wasnt discussed when you started treatment And again, for severe pain, allergic reactions, or signs of serious illness, seek care immediately