"The substantial improvements in lung function and other measures of CF seen in these Phase 3 studies are unprecedented and represent a defining moment in the journey to provide medicines that treat the underlying cause of CF to the vast majority of people with CF," said Steven Rowe of University of Alabama.
Vertex plans to submit a New Drug Application to the US Food and Drug Administration in Q3 of 2019 and a Marketing Authorization Application to the European Medicines Agency in Q4.
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