| 1.0 |
Proposal Preparation & Submission |
Align proposal with NINDS priorities. |
Sat, Mar 1, 2025 |
Wed, Apr 30, 2025 |
| 1.1 |
Review RFA & Align Proposal |
Ensure feasibility and study design fit. |
Sat, Mar 1, 2025 |
Wed, Apr 30, 2025 |
| 1.2 |
Letter of Intent (LOI) Submission |
LOI submission 30 days before deadline. |
Fri, May 9, 2025 |
Fri, May 9, 2025 |
| 1.3 |
Full Proposal Development |
Draft research strategy and methodology. |
Tue, Apr 1, 2025 |
Sat, May 31, 2025 |
| 1.4 |
Internal Review & Revisions |
Conduct internal review and refine submission. |
Sat, May 10, 2025 |
Thu, Jun 5, 2025 |
| 1.5 |
Proposal Submission |
Submit full proposal to NINDS by deadline. |
Mon, Jun 9, 2025 |
Mon, Jun 9, 2025 |
| 1.6 |
IND-Enabling Studies |
Prepare study for IND submission. |
Tue, Jul 1, 2025 |
Tue, Jun 30, 2026 |
| 2.0 |
Assay Development & Validation |
Develop and validate bioassays. |
Tue, Jul 1, 2025 |
Tue, Jun 30, 2026 |
| 2.1 |
Preclinical Toxicology & PK/PD Studies |
Conduct toxicology and PK/PD studies. |
Tue, Jul 1, 2025 |
Thu, Dec 31, 2026 |
| 2.2 |
cGMP Manufacturing & Drug Formulation |
Scale up GMP manufacturing and formulation. |
Wed, Oct 1, 2025 |
Wed, Mar 31, 2027 |
| 2.3 |
IND Submission & Clinical Trial Readiness |
Prepare IND application and ensure compliance. |
Wed, Jul 1, 2026 |
Wed, Mar 31, 2027 |
| 2.4 |
IND Preparation & Filing |
Submit IND application to the FDA. |
Wed, Jul 1, 2026 |
Wed, Mar 31, 2027 |
| 2.5 |
Clinical Site Selection & IRB Approvals |
Select clinical trial sites and secure approvals. |
Thu, Oct 1, 2026 |
Wed, Jun 30, 2027 |
| 2.6 |
First-in-Human Dosing |
Begin human dosing in clinical trials. |
Wed, Sep 1, 2027 |
Fri, Dec 31, 2027 |
| 2.7 |
Clinical Trial Execution |
Execute clinical trial as per study design. |
Thu, Jul 1, 2027 |
Fri, Mar 31, 2028 |
| 2.8 |
Patient Recruitment & Enrollment |
Recruit and enroll study participants. |
Thu, Jul 1, 2027 |
Fri, Mar 31, 2028 |
| 3.0 |
Safety & Efficacy Monitoring |
Monitor patient safety and efficacy outcomes. |
Thu, Jul 1, 2027 |
Sun, Dec 31, 2028 |
| 3.1 |
Final Data Analysis & Reporting |
Analyze and report trial results. |
Sun, Apr 1, 2029 |
Sat, Jun 30, 2029 |
| 3.2 |
Task 3.2 |
Description for Task 3.2 |
Tue, Jul 1, 2025 |
Tue, Jun 30, 2026 |
| 3.3 |
Task 3.3 |
Description for Task 3.3 |
Tue, Jul 1, 2025 |
Tue, Jun 30, 2026 |
| 3.4 |
Task 3.4 |
Description for Task 3.4 |
Tue, Jul 1, 2025 |
Tue, Jun 30, 2026 |
| 3.5 |
Task 3.5 |
Description for Task 3.5 |
Tue, Jul 1, 2025 |
Tue, Jun 30, 2026 |
| 3.6 |
Task 3.6 |
Description for Task 3.6 |
Tue, Jul 1, 2025 |
Tue, Jun 30, 2026 |