USFDA Completes Pre-approval Site Inspection:

Cyclopharm Limited (ASX: CYC) today advises that the United States Food and Drug Administration (USFDA) has completed the site inspection of the company’s manufacturing facility at Kingsgrove, New South Wales, which was undertaken between 31 July and 8 August, 2023.

Cyclopharm CEO James McBrayer said “Technegas will be regulated in the United States as combination product.

The inspection covered both the drug and device elements of Technegas.”

 “While the inspection report will require further internal FDA review before it is final, we are pleased with the process and are confident that our USFDA’s goal review date of 29 September 2023 remains on track,” Mr McBrayer said.  

As previously advised, Cyclopharm confirms its expectation that USFDA approval will create an initial addressable market in the USA of US$180 million per annum in the diagnosis of Pulmonary Embolism (PE). 

This estimate does not include the exponentially larger potential for Technegas’ application for Beyond PE indications, including the diagnosis and management of Chronic Obstructive Pulmonary Disease, lung cancer, asthma and Long COVID.