The trial is being conducted under a Special Protocol Assessment (SPA) granted by the US Food and Drug Administration (FDA), which ensures that the agreed clinical trial design meets the FDA’s expectations for a pivotal study.
Allon president and CEO Gordon McCauley said the pace of enrollment is a testament to the patients, caregivers, investigators, and advocacy groups who have been tremendous partners, and certainly hope this trial to generates data necessary for marketing approval of davunetide as a treatment for PSP.
The multi-national study is being conducted at premier medical institutions in the US, Canada, the UK, France, Germany and Australia.