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Stealth’s Elamipretide Gets US FDA Review, But Same Questions Linger

 
• By Derrick Gingery

The Barth Syndrome candidate application will be reviewed by the FDA, but Stealth BioTherapeutics' CEO tells the Pink Sheet that the company still does not have clear guidance on how or whether it should gather additional clinical data.

conference room table
Elamipretide's NDA filing provides a seat at the table, but Stealth BioTherapeutics still has work to do, its CEO said. • Source: Shutterstock

Stealth BioTherapeutics Inc. still faces many of the known questions and uncertainties about its Barth Syndrome candidate elamipretide even with the application now in the hands of the US Food and Drug Administration.

After an extended stalemate with the FDA related to the necessary clinical data, the agency has agreed to file the elamipretide application, Stealth announced on 8 April

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