FDA Request on Capsule Manufacturing Delays Phase 2b Trial of Tesomet

FDA Request on Capsule Manufacturing Delays Phase 2b Trial of Tesomet

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FDA Request on Capsule Manufacturing Delays Phase 2b Trial of Tesomet

A planned Phase 2b trial of Tesomet in treating Prader-Willi syndrome (PWS) is being pushed back to later this year, following a request from the U.S. Food and Drug Administration (FDA) for more information on the medication’s manufacturing. “While we are disappointed to delay the initiation of our Phase 2b clinical trials of Tesomet in PWS and [hypothalamic obesity], we are encouraged that we have clear agreement from the FDA regarding our development plans as they…

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