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Island Pharmaceuticals Seeks FDA Nod to Fast-Track Galidesivir for Marburg
8:55am on Monday 1st of September, 2025 AEST
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Pharmaceuticals
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Island Pharmaceuticals Seeks FDA Nod to Fast-Track Galidesivir for Marburg
8:55am on Monday 1st of September, 2025 AEST
Key Points
Type C meeting request lodged with FDA on 29 August 2025
Seeking alignment on Animal Rule to expedite Galidesivir approval
Planned animal efficacy study for Marburg to start and finish next quarter
Meeting expected in Q4 2025 to discuss study design and regulatory feedback
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