Radiopharmaceutical company Cyclopharm (ASX:CYC) is pleased to announce that the United States Food and Drug Administration (USFDA) has granted the Company a full application fee waiver of USD $2.9 million related to its recently submitted New Drug Application (NDA) for Technegas.
Technegas is a nuclear medicine functional lung ventilation imaging agent.
The USFDA can waive the application fee for the first human drug application that a small business or its affiliate submits for review.
A small business is defined as a business that has fewer than 500 employees, including employees of affiliates.
The United States is the largest nuclear medicine market in the world.
Cyclopharm estimates the size of the US market for Technegas® in diagnosing the presence of Pulmonary Embolism (PE) to be US$90 million in sales per annum.
We expect to gain a 50% share of this market in the first 2 to 3 years, rising to 80% over 5 to 7 years.
Shares in Cyclopharm (ASX:CYC) are trading 6.15 per cent higher at $1.38.