Cyclopharm (ASX:CYC) has submitted its formal reply to the US FDA's Complete Response Letter for its Technegas lung imaging agent.
The submission initiates the FDA's six-month review process, the final major approval hurdle for Technegas in the United States.
Cyclopharm expects FDA approval and Technegas sales to begin in the US, creating an initial addressable market of $180 million per annum for its product for the diagnosis of pulmonary embolism.
This estimate does not include potential use of Technegas for the diagnosis and management of chronic obstructive pulmonary disease, lung cancer, asthma, and long COVID.