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FDA provides path forward for Prosensa DMD drug drisapersen

This article was originally published in Scrip

Executive Summary

Investors rallied around shares of Dutch biotech Prosensa in premarket trading on 3 June on word the FDA had provided a way forward for the company to file a new drug application (NDA) under an accelerated approval pathway for its experimental Duchenne muscular dystrophy (DMD) drug drisapersen, although with a tone of skepticism.

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