Has the FDA cleared or permitted a Phase 3 trial of Saltikva?

Following a Type C meeting, the FDA permitted Salspera, Inc. to proceed to a Phase 3 trial of Saltikva in stage IV metastatic pancreatic cancer on the basis of the Phase 2 results. The Phase 3 design has not been finalized, and no Phase 3 trial is active or recruiting. The S-1/A No. 3 ↗ describes the meeting as providing an initial framework for a randomized study.

The planned Phase 3 is a global, multisite, randomized controlled trial intended to support a Biologics License Application. Saltikva holds FDA Fast Track and Orphan Drug Designations for pancreatic cancer; these are process designations, not approvals.