Snippet from RNS5 May 2020 14:41
The Company is seeking to enter the novel COVID-19 diagnostics market. The Directors believe it is impossible to predict the full nature, extent and duration of the COVID-19 pandemic and therefore the total demand for COVID-19 diagnostic tests and the longevity of this demand are uncertain. Furthermore, the introduction of breakthrough therapeutic drugs or vaccines could reduce the requirement for widescale diagnostic testing of COVID-19 and the importance of contact tracing.
The ability of the Company to commercialise its COVID-19 tests is dependent on the ability to obtain regulatory approvals in relevant markets. genedrive intends to obtain a CE mark for its COVID-19 tests but the tests are currently unapproved. Under section 564 of the Federal Food, Drug, and Cosmetic Act, the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by a terrorist attack with a biological, chemical, or radiological/nuclear material, or a naturally occurring emerging disease when there are no adequate, approved, and available alternatives (Emergency Use Approval). On 4 February 2020, the US Department of Health and Human Services Secretary declared that circumstances exist justifying the authorisation of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19. On 29 February 2020, the FDA issued an immediately in effect guidance with policy specific to development of in vitro diagnostic tests during this public health emergency, which was subsequently updated on 16 March 2020. There is no certainty that the FDA will continue to allow Emergency Use Authorisation either due to the development of adequate, approved and available alternatives or due to the COVID-19 pandemic no longer being considered sufficiently serious to justify emergency use of in vitro diagnostics. If the FDA withdraws the Emergency Use Approval, the ability of the Company to commercialise its COVID-19 diagnostic tests would be adversely affected in the US and other markets.
Sensible statement and staying grounded.