Cyclopharm Limited (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 $2.9m related to its recently submitted New Drug Application (NDA) for Technegas®, 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.
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