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Chelsea’s Northera: The Perils of Drawing Conclusions in Real Time

This article was originally published in RPM Report

Executive Summary

Despite a “yes” vote from an advisory committee, FDA sent Chelsea’s Northera back to the development phase with a complete response letter asking for data from another trial. There may have been nothing Chelsea could have done to get a better result—but the company could have held off on a post-panel victory lap.

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