Aug. 1 at 5:49 PM
$REGN This has a good chance of being [resolved] expeditiously," said CEO Leonard Schleifer on the company's second-quarter earnings call Friday morning. "These were not structural changes that are being requested by the FDA. It's not like they have to rebuild something… They're mainly process [and] procedural, those sorts of things."
"We are expecting — once the resolution of the filling issues has occurred — to receive favourable action, we hope, from the FDA," he added.