Triferic’s ESA-Reduction Claim Draws FDA Skepticism Ahead Of ODAC Review
This article was originally published in The Pink Sheet Daily
Executive Summary
Rockwell’s iron replacement therapy could be hindered by absence of ESA-reduction claim even if drug makes it through FDA with more limited indication; agency will have to address its own discrepancies in briefing document data at the Nov. 6 Oncologic Drugs Advisory Committee.