March 31, 2026
Dear Members of the PDCD Community,
We are deeply grateful for your support and advocacy throughout this process, particularly as
we have worked to navigate the FDA’s Complete Response Letter and identify a path forward
for SL1009 (DCA). Over the past several months, this community has shown up in meaningful
ways by sharing your stories, engaging with policymakers, and continuing to push for progress
when it mattered most. That collective effort has made a difference.
On March 26th, we held our Type C meeting with the FDA to discuss the potential resubmission
of our New Drug Application for SL1009 (DCA) for Pyruvate Dehydrogenase Complex
Deficiency (PDCD). We were encouraged by the outcome of this meeting. The Agency provided
guidance on the content and focus of the resubmission, helping to further clarify a feasible path
forward. Importantly, no additional meetings were requested at this time, allowing us to move
ahead with preparing our resubmission.
While work remains, we view this as meaningful progress and a step forward that reflects not
only the data but the strength and unmet needs of this community. We are moving forward with
urgency and remain focused on bringing this therapy to individuals with PDCD as quickly as
possible. As we continue this process, we will keep advocating for regulatory flexibility and
speed.
Thank you for continuing to stand with us and with one another. We’re committed to moving
forward together.
With gratitude,
Dave Penake, CEO
Saol Therapeutics Inc.
