Final Operational Milestone #6

All experiments and manufacturing listed in the original application have been completed.  We have submitted an IND to the FDA for a first-in-human Phase I clinical trial for late-onset adult Tay-Sachs patients.  We have received responses back and the FDA has requested additional release testing on the clinical lot of the lentiviral vector as well as additional experiments based on our original results.  These will be completed by the end of May 2025 provided acceptance of our PPAC request.  We will then submit an amendment to our IND and wait to receive an active IND to conduct the Phase I trial.