The Omniscient Regulator: QRxPharma’s Unusual Take on FDA and Investor Calls
This article was originally published in RPM Report
Executive Summary
Investor calls routinely begin with a disclaimer that the call is being recorded. They don’t usually include a warning that “FDA is monitoring the call.” But that is how QRxPharma began a discussion of a bad news event for its MoxDuo application.
You may also be interested in...
SEC Sues Imaging3 For Misleading Investors About FDA Device Review
The Securities and Exchange Commission says the imaging equipment firm’s founder and CEO made misleading public statements about the contents of a 2010 “not substantially equivalent” letter from FDA for Imaging3’s investigational Dominion 3-D, real-time imaging system.
Arena Must Deal With Rat Neoplasms To Move Forward With Lorqess
A major task confronting Arena as it pursues approval of Lorqess is to provide FDA with an explanation that shows the neoplasms found in rats during animal studies of the obesity drug are not a predictor of cancer risk in humans.
FDA Develops Formal Procedure To Refer Misleading Communications To SEC
Associate Commissioner for Regulatory Affairs John Taylor will serve as the liaison between the agencies. FDA will provide "blanket" authorization to certain staff to share non-public information with SEC.