Oh dear Sona29 Oct 2020 14:30
Halifax, Nova Scotia--(Newsfile Corp. - October 29, 2020) - Sona Nanotech Inc. (CSE: SONA) (OTCQB: SNANF) (the "Company"), a developer of rapid, point-of-care diagnostic tests, received notice from the FDA that the Company's request for an emergency use authorization ("EUA") for the marketing of its rapid COVID-19 antigen test in the United States "is not a priority" and consequently such authorization will not be issued at this time. The FDA cited current EUA request prioritization criteria as including "the public health need for the product" and did not comment on the performance of the Sona test.
Health Canada continues its evaluation of the Company's application for an Interim Order ("IO") authorization for its test as a 'point-of-care' medical diagnostic device. The Company yesterday received additional questions on its application. Also, Health Canada has submitted the Company's tests to the Public Health Agency of Canada's National Microbiology Laboratory for evaluation, which is ongoing.
Sona has already sold tests to Canadian companies under 'research use only' labelling. These tests are being evaluated as a screening tool for the identification of COVID-19 amongst employees. Potential programs envision having employees that test positive with the Sona rapid test designated 'presumed positive', removed from congested work environments and referred to medical professionals for confirmatory testing. This process would allow employers to remove affected staff from the work place, reduce potential spread and help businesses remain open in pandemic conditions. The Company believes that screening individuals in congested environments, whether they be mining operations, airports or long-term care facilities is the best use case for Sona's rapid test and that this added testing tool can play an important role in Canada's response to Covid-19. These tests were manufactured in the Company's in-house manufacturing facility.
The Company continues its manufacturing scale-up activities, having run multiple pilot production batches with a contract manufacturing organization, and is in advanced discussions with other manufacturers. The Company expects to be in a position to ship commercial tests to customers in November, subject to regulatory approval.
Sona still worth $200m. The lengthy delay in FDA EUA approval time for Sona was the writing on the wall really.
Paraytec will show the world how a test is really done..
Sign In
Follow the stocks
