FDA-IND Application for Intermediate Size Group Population Expanded Access:
1. Outline of Materials
2. FDA-IND-1571: Expanded Access Form
3. Financial Interests of Investigator Form
4. Statement of Investigators Form
5. Principal Investigator & Co-PI CV
6. Statement of Purpose, Background
7. Proposed Research Project Background
8. Current Provisional Patent Claims
9. Clinical Design, Aims, Goals & Budget
10. Research Validation Brain Imaging
11. Research Consent, IND Disclosures
12. Formula: Pharmacology-Toxicology Data
13. Current Thesis Research Outline
14. Commercial Pitch Deck with Societal Impact Statement, Referenced Background, Commercial Potentials Real Time Revenue Model




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