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AdAlta Opens FDA Pathway for EW-001 Mesothelioma CAR-T
8:17am on Wednesday 23rd of September, 2026 AEST
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Biotechnology
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AdAlta Opens FDA Pathway for EW-001 Mesothelioma CAR-T
8:17am on Wednesday 23rd of September, 2026 AEST
Key Points
FDA accepts pre-IND meeting request for EW-001
Meeting to address manufacturing, non-clinical studies and Phase 1 design
Australian manufacturing transfer and clinical protocol preparation completed to briefing stage
FDA meeting scheduled for 3 November US time
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