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Pfizer Vyndaqel Advisory Committee Pits Orphan Flexibility Vs. Data Shortcomings

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA finds much to question in a single pivotal trial of Pfizer’s orphan drug Vyndaqel (tafamidis meglumine) for familial amyloid polyneuropathy, but the ultra-orphan nature of the disease may outweigh those concerns.

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