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Misreading FDA: Meeting Minutes Reality Sinks Amicus

This article was originally published in Scrip

Executive Summary

When Amicus Therapeutics Inc. met with the FDA this past spring and again just a few weeks ago, the company walked away from both meetings thinking regulators were on board with the idea the biotech was ready to submit its new drug application (NDA) for migalastat as a treatment for Fabry disease under the agency's accelerated approval pathway, or Subpart H – a plan the firm intended to carry out in the fourth-quarter.

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