Xpovio's US FDA Review: A Primer On How (Not) To Submit Real-World Data
Karyopharm included a real-world data study to support its Xpovio NDA, but the US FDA deemed the study inadequate for an overall survival comparison to the pivotal STORM trial.
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Karyopharm included a real-world data study to support its Xpovio NDA, but the US FDA deemed the study inadequate for an overall survival comparison to the pivotal STORM trial.