Cyclopharm (ASX:CYC) has announced that it has been notified that the US FDA will inspect the company's Kinsgrove facility between late July and early August.
It said the inspection notification follows last month’s confirmation by the US regulator of a six-month review period of Cyclopharm’s New Drug Application for its proprietary lung ventilation imaging agent, Technegas.
Cyclopharm CEO James McBrayer said he was pleased that the inspection is scheduled for a period within the FDA's goal review period.