Impasse At US FDA Could Mean Stealth Abandons Barth Syndrome Treatment

In an interview with the Pink Sheet, Stealth’s CEO says she is not confident the company could design a clinical trial in the rare disease that would meet the FDA’s expectations.

impasse
Stealth Biotherapeutics left a Type A meeting with the FDA not knowing what to do to push the elamipretide development program forward. • Source: Shutterstock

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