RE: Brilliant RNS14 Oct 2020 19:13
Fabulous news guys
- Synairgen has had a positive pre-IND meeting with the U.S. FDA for SNG001 for a Phase III study for the treatment of COVID-19. A pre-IND meeting provides an opportunity for an open communication between the sponsor and the FDA to discuss the IND development plan and to obtain the FDA's guidance on clinical studies for the sponsor's new drug candidate.
- On 14 October 2020 the Company was informed by the National Institute for Health Research (NIHR) that the Phase III trial has been badged in the UK as Urgent Public Health and will be recognised as a National Priority study. Notwithstanding this, the commencement of the trial will still be subject to normal regulatory and ethical approvals.