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How Will PYC’s FDA-Backed Trial Design Transform RP11 Treatment?
9:06am on Monday 23rd of June, 2025 AEST
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Biotechnology
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How Will PYC’s FDA-Backed Trial Design Transform RP11 Treatment?
9:06am on Monday 23rd of June, 2025 AEST
Key Points
FDA approves sham control arm and inclusion/exclusion criteria for VP-001 trial
Either Low Luminance Visual Acuity or Microperimetry can serve as primary endpoint
Minimum 24 months of data required to support New Drug Application
PYC plans to finalize trial design and seek FDA protocol endorsement in H2 2025
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