Conclusions
1 evidence topic · 5 sources
Summary
SL1009 remains investigational. The FDA found the original application insufficient to establish effectiveness and rejected the proposed external-control survival comparison as a basis for assessing treatment effect. The sponsor subsequently reported resubmission on June 30, 2026, acceptance as a complete Class 2 response, and a target FDA action date of December 30, 2026. Acceptance for review is not approval. Ketogenic dietary therapy remains a recommended treatment for primary PDCD; the evidence in this report does not establish that SL1009 should replace it.