The data and the bit about going for 8yesrs market exclusivity4 Feb 2025 19:55
The phase 2 results also demonstrated an on average 86% abstinence rate in the 6 months post treatment versus 2% abstinence pre-trial.
Regulatory path and exclusivity: Awakn is targeting a Regulation 52b hybrid application in the UK for AWKN-001. If successful, this could provide 8 years of market exclusivity, with an additional 2 years of supplementary protection, preventing competitors from marketing a similar product for the same indication. Awakn is planning to commence market access discussions with the UK Department of Health this year.