Adial Provides Business Update Following Favorable Comments from US and EU Regulatory Meetings
Reviewed the safety data from the ONWARD trial and did not express any concerns with the data.
- Reviewed the safety data from the ONWARD trial and did not express any concerns with the data.
- Confirmation of the importance of identifying a patient subgroup where a relevant treatment effect and compelling evidence of a favorable risk-benefit profile can be assessed.
- The new clinical development plan includes both the US and EU endpoints and will be designed to satisfy both US and EU AD04 submission requirements.
- Confirmation of the clinical development plan and pathway is currently being conducted by Adial’s clinical development and regulatory advisors.