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Chelsea’s Northera Plan: Expand Ongoing Study While Assuring Integrity Of Older Data

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Chelsea said it will address FDA’s “complete response” letter by modifying and enlarging an ongoing droxidopa clinical trial and submitting all patient source documentation from an ex-U.S. study site in the completed pivotal trial that the agency has called into question.

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