SpringWorks fixes 'minor data handling error' after March Form 483 for trial site linked to upcoming PDUFA

The FDA issued SpringWorks Therapeutics a Form 483 on March 31, saying that the company’s own clinical trial protocols were not followed.

But SpringWorks COO Badreddin Edris told Endpoints News in a phone interview on Monday that “it was a minor data handling error on an exploratory endpoint that was corrected within a week in March and resulted in no impact on the data” that formed the basis of the company’s application for its first “pipeline-in-a-product” oncology treatment, the oral gamma secretase inhibitorgamma secretase inhibitor, dubbed nirogacestat, or Ogsiveo.

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来源: EndPoints

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