Abbott Atrasentan Meta-Analysis Of Failed Trials Is "Centerpiece" Of NDA
This article was originally published in The Pink Sheet Daily
Executive Summary
The company plans to complete the NDA filing for Xinlay in metastatic prostate cancer by year-end, which is ahead of the timetable predicted after a pivotal trial failed to reach statistical significance. A Phase III trial in a second indication is likely to finish in 2005.
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FDA's Oncologic Drugs Advisory Committee unanimously recommends against approval of Abbott's prostate cancer therapy atrasentan.
Abbott Xinlay Not Ready For Approval Or Abandonment, Committee Says
FDA's Oncologic Drugs Advisory Committee unanimously recommends against approval of Abbott's prostate cancer therapy atrasentan.
Ongoing Phase III Study Could Provide Xinlay Back-Up Option, Abbott Says
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