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FDA Greenlights Single Pivotal Trial for Cambium Bio’s Elate Ocular, Slashing Costs and Timelines
1:42pm on Thursday 23rd of April, 2026 AEST
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Healthcare
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FDA Greenlights Single Pivotal Trial for Cambium Bio’s Elate Ocular, Slashing Costs and Timelines
1:42pm on Thursday 23rd of April, 2026 AEST
Key Points
FDA endorses single pivotal Phase 3 trial for Elate Ocular BLA
Development costs and enrolment timelines substantially reduced
Phase 3 study design remains unchanged with 400 evaluable patients
Fast Track Designation enables rolling BLA submission
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