FDA-IND Application for Expanded Use & NDC Registrations 01/01/2022

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