Quarterly Activities/Appendix 4C Cash Flow Report
Filed with ASX · · 12 pages · English
● U.S. Pilot Study Delivers Strong Diagnostic Outcomes Supporting Progression to FDA Trial: BlinkLab’s U.S. autism pilot study of 485 children delivered 83.7% sensitivity and 84.7% specificity, significantly exceeding the performance thresholds discussed with the FDA (>65% / >65%) and de-risking progression into the pivotal 510(k) registrational trial. ● Regulatory Alignment with U.S. FDA: BlinkLa
Earlier from Blinklab
- High-Profile Journal Publication Validates BB1 Technology
- Appointment of Managing Director and Board Changes
- Pilot Study Confirms High Diagnostic Accuracy & Readiness
- 2025 Annual Report & Appendix 4E
- US Ethics Approval Received for the Main Phase of FDA510(k)
Later from Blinklab
- Half Yearly Report and Accounts
- Clinical Trial Network for Pivotal FDA Study Complete
- Trading Halt
- Morocco's Nationwide Government-Funded Autism Screening
- Validation Program Commences-FDA 510(k) - First Participant
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