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Alnylam's Onpattro: Not Following FDA Guidance Amplifies Clinical Meaningfulness Concerns

Executive Summary

Even if Alnylam can get a favorable advisory committee vote and is able sneak out an approval for Onpattro for ATTR-associated cardiomyopathy, its lack of data on hard clinical outcomes makes it unlikely to unseat Pfizer’s tafamidis for the rare disease.

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