Approval received for NTI164 Phase 3 Clinical Study in ASD
Filed with ASX · · 2 pages · English
• Human Research Ethics Committee approval secured to commence Neurotech’s Beyond Harmony Phase 3 clinical study of NTI164 in ASD Levels 2 and 3. • Study is designed to support regulatory submissions for NTI164 in Australia (TGA) and the United States (FDA). • The Phase 3 design is informed by Neurotech’s prior ASD studies showing statistically significant, clinically meaningful improvements acros
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Earlier from Neurotech International
- Quarterly Activities/Appendix 4C Cash Flow Report
- Binding Commitments Received for a $4 Million Placement
- Trading Halt
- Neurotech receives $4.73m R&D Tax Incentive Refund
- US FDA Rare Pediatric Disease Designation in Rett syndrome
Later from Neurotech International
- Positive 90-day GLP toxicology study results in non-rodents
- Appendix 4D & Half Year Report
- NTI initiates First Clinical Site for Phase 3 ASD Trial
- NTI secures Notices of Allowance for US patent applications
- US FDA clears IND for NTI164
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