Genelabs To Meet With FDA Following Positive Open-Label Prestara Study
This article was originally published in The Pink Sheet Daily
The study was an extension of a previous Phase III study that failed to meet its primary endpoint of increased bone mineral density at the lumbar spine.
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The trial was designed to meet FDA's "approvable" letter request for confirmation of bone mineral density increases in women with lupus receiving glucocorticoids. Genelabs plans to meet with the agency when it completes data analysis.
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