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Genfit Delays NASH Data While It Confers With US FDA On Methodology

 
• By Joseph Haas

Genfit will delay unblinding of data from its nearly complete Phase III study of elafibranor to get insight from the FDA on statistical methods in order to optimize its NDA.

Data Collection - Three Arrows Hit in Red Target
Genfit will await FDA insight on statistical methodology before unblinding its Phase III NASH study

Genfit SA says its decision to push back the unblinding of its Phase III RESOLVE-IT study of elafibranor in non-alcoholic steatohepatitis (NASH) until it receives “insights” from the US Food and Drug Administration about statistical methodology is aimed at putting together the best possible new drug application (NDA).

Investors seem to have taken the news in stride; the company’s stock closed at $17

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