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NSB clears FDA hurdle for StemSmart Crohn’s trial
9:08am on Tuesday 27th of October, 2026 AEDT
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Biotechnology
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NSB clears FDA hurdle for StemSmart Crohn’s trial
9:08am on Tuesday 27th of October, 2026 AEDT
Key Points
FDA supports six of seven key elements of the proposed Phase 2 trial
No additional non-clinical studies required under current human data package
Southern Star Research appointed to run the Australian and US trial
Q-Gen manufacturing transfer and TGA inspection remain execution milestones
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