As is standard, we have received a request for further information from the MHRA, and a company response is due to be submitted in late February 2025.
We welcome the flexibility and commitment shown by the MHRA and NICE to process our application, and we will continue to work with them to address one of the world’s greatest unmet medical needs.
A paper reporting the latest Phase 3 trial of HMTM is currently undergoing peer review. The results from earlier trials have been previously reported in peer-reviewed publications, and these have been consistent in showing clinically meaningful therapeutic activity on cognitive decline and brain shrinkage.
