Australian company Cyclopharm (ASX:CYC) has announced that the US FDA has granted it a full application fee waiver of US$2.9m related to its recently submitted New Drug Application (NDA) for Technegas.
Technegas is a nuclear medicine functional lung ventilation imaging agent. The FDA 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.
Cyclopharm managing director and CEO James McBrayer said, “Whilst we were confident that we were eligible for a fee waiver, we are very grateful to the USFDA in their support of small business and the speed at which our application was granted. What normally takes three to four months to review, our request was granted in two months.”
Mr McBrayer continued, “Our approval was based on our small business status; however, to de-risk the process, the Company also submitted additional waiver applications under the categories of public health and a barrier-to-innovation."
He said additional applications related to the potential incremental benefits of Technegas and its intended use for the diagnosis of a life-threatening condition.
Mr McBrayer added, “Having recently submitted our Technegas New Drug Application to the USFDA, and now obtaining the full fee waiver, the next important step in the process is concluding the USFDA sixty-day review of our NDA submission for completeness and the subsequent granting of an Approval to File.
"During this sixty-day period the USFDA will also determine if our application for Priority Review will be granted. The request for a Priority Review, as opposed to the Standard Review, will reduce our timeline to market by four months. Both Approval to File and the review period determination is expected to be decided by 27 May 2020.”