NasdaqGS:GRALBiotechs
What GRAIL (GRAL)'s FDA PMA Submission for Galleri Test Means For Shareholders
GRAIL, Inc. previously submitted the final module of its Premarket Approval application to the U.S. FDA for its Galleri multi-cancer early detection test, drawing on performance and safety data from the large PATHFINDER 2 and NHS-Galleri trials and supported by a bridging analysis to the updated test version.
This milestone builds on the FDA’s earlier Breakthrough Device designation and centers on extensive real-world screening data to assess Galleri’s clinical utility.
We’ll explore how...