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FDA Panel Backs Palovarotene for Ultra-Rare Bone Disorder

by MedPage Today | June 29, 2023
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Committee chair Cecilia Low Wang, of the University of Colorado Anschutz Medical Campus in Aurora, said these analyses, while not ideal, support palovarotene’s efficacy. “Despite problems with post hoc analyses in general, and the fact that these were performed after the data were unblinded, I felt that they were appropriate in this instance,” said Wang. “The results were convincing and consistent as performed by the sponsor, and especially because these were confirmed by the FDA.”

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