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AGORA
2024-2027
3H Bio timeline for Business and Anti-Obesity Medicine Development
-2025. Oct: US FDA IND Application
-2026. Apr: Report of Clinical Phase 1a Study in Australia
-2026. Sep: Report of Clinical Phase 1b Study in Australia
Clinical 3HOTP - FDA IND (CBER) development process
| Task | 2025 | 2026 | |||||||||||
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| ~June | July | Aug | Sep | Oct | Nov | Dec | Jan | Feb | Mar | Apr | |||
| FDA | Engineering Batch |
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| CTM Manufacture |
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| Gap analysis for IND |
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| Clinical protocol |
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| Pre-IND Activities |
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| IND preparation & submission (Module) | M 1 |
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| M 2 |
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| M 3 |
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| M 4&5 |
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| IND Submission | |||||||||||||
| Australia | IRB |
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| Phase 1a |
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| Phase 1b |
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