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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)

A third-party vendor undermined Applied Therapeutics’ bid to bring the first drug for the rare genetic metabolic disease galactosemia to market by deleting electronic clinical outcome assessment data for the govorestat pivotal trial.

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