FDA Panel To Take Second Look After J&J Plugged Holes In Xarelto ATLAS Data
This article was originally published in The Pink Sheet Daily
Executive Summary
Broader issue of missing data in clinical trials could see further discussion as FDA’s Cardiovascular and Renal Advisory Committee will relook at Xarelto’s acute coronary syndrome indication Jan. 16, now that J&J has tried to address the missing data that befuddled the committee on the first go-round.