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How Will Argenica Overcome FDA’s Clinical Hold on ARG-007 Stroke Trial?
9:15am on Thursday 14th of August, 2025 AEST
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Healthcare
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How Will Argenica Overcome FDA’s Clinical Hold on ARG-007 Stroke Trial?
9:15am on Thursday 14th of August, 2025 AEST
Key Points
FDA requests additional safety data from ongoing Phase 2 trial
Three new in vitro studies mandated, including cardiac and genotoxicity assays
Argenica to update investigational brochure with more Phase 1 data
Studies to be conducted with clinical research organisations (CROs)
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