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Misreading FDA: Meeting Minutes Reality Sinks Amicus

 
• By Donna Young

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.

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.

But Amicus disclosed on Oct. 2 the FDA actually had been under a completely different impression and had determined more...

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• By Kevin Grogan

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• By Sarah Karlin-Smith, Mandy Jackson, and Mary Jo Laffler

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