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Island Pharmaceuticals Secures FDA Meeting to Fast-Track Marburg Virus Drug
9:37am on Friday 19th of September, 2025 AEST
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Pharmaceuticals
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Island Pharmaceuticals Secures FDA Meeting to Fast-Track Marburg Virus Drug
9:37am on Friday 19th of September, 2025 AEST
Key Points
FDA grants Type C meeting under Galidesivir’s open IND application
Opportunity to align on Animal Rule use for accelerated approval
Clarification sought on animal study design and Priority Review Voucher eligibility
Written FDA feedback expected by 12 November 2025
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