Deleted Clinical Trial Data Derailed Applied Therapeutics’ Govorestat NDA

 
• By Bridget Silverman

An FDA complete response letter followed a bioresearch warning letter citing the integrity of electronic data capture and handling of dosing errors in a pivotal trial of govorestat for galactosemia.

Applied Therapeutics' handling of deleted clinical trial data and dosing errors in a pivotal trial helped govorestat receive a complete response letter. (Shutterstock)

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