Keeping Track: A Lawsuit-Driven Complete Response Letter, A Refuse To File Letter, And Some Good News
Executive Summary
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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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.
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Impasse At US FDA Could Mean Stealth Abandons Barth Syndrome Treatment
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