12/22/2025
From Shawn, Tara, Kaeli, and the rest of the MLD team, we want to wish everyone a safe and happy holiday season. Early in 2026 we will provide a more complete program update with tentative timelines. Our current focus is on getting a face-to-face meeting with the Agency, as they have indicated they would like to meet to discuss the overall trial design including confirmation of endpoints and details on how to safely dose escalate in patients. As you are aware, the FDA is in a state of chaos and combined with the shutdown, there have been delays in timeline across the board. The whole process continues to be slower than we would like, but all we can do is hope the FDA agrees to a productive discussion about the program and we eventually get this study going (especially since we just packaged all the drug for this study this week!!).
Our little team is as dedicated as ever to getting a safe plasmalogen therapy available for RCDP patients. We will get there! Have a great holiday season and we will be in touch in the new year.
Sincerely,
The MLD team