Galera Therapeutics sues CROs over Phase 3 ROMAN trial statistical error

Galera Therapeutics, Inc.

Filed lawsuit in Pennsylvania against Alira Health Clinical and IQVIA Biotech for breach of contract and negligence.
Error in 2021 statistical program for Phase 3 ROMAN trial corrected; yielded statistically significant p-values for primary and key secondary endpoints.
Litigation is in early stages; company cannot predict outcome at this time.
FDA accepted NDA for avasopasem with Priority Review; PDUFA target date August 9, 2023.

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