Cyclopharm confirms USFDAs planned inspection date

Cyclopharm Limited (ASX: CYC) announces that the United States Food and Drug Administration (USFDA) has informed the business that an inspection of the business's Kingsgrove, New South Wales facility will be undertaken between 24 July and 04 August 2023. The inspection notification comes after the USFDA confirmed a six-month review period for Cyclopharm's New Drug Application for its exclusive lung ventilation imaging agent, Technegas, expiring on 29 September 2023.

The USFDA's approval, according to Cyclopharm, will result in a US$180 million annual addressable market for the diagnosis of pulmonary embolism (PE). This estimate excludes the exponentially more significant potential for Technegas' applicability Beyond PE conditions, such as diagnosing and treating lung cancer, asthma, Long COVID, and Chronic Obstructive Pulmonary Disease.

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