Company: JUNS
Filing Date: 2025-11-26
Form Type: S-1
Source: 0001493152-25-025204
Chunk: 163

Company: JUPITER NEUROSCIENCES, INC.
Filing Date: 2025-11-26
Form: S-1
Chunk 163
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 disease, and the drug using a voucher for another indication. The voucher may be sold. For example,
a small company might win a voucher for developing a drug for a neglected disease and sell the voucher to a large company for use on a
commercial disease.

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There are four specific approval
pathways applicable for rare disease indication. We will be evaluating and most likely applying for one or more of these when we get closer
in the FDA approval process. These include the following pathways for the indications that it is targeting: (1) Priority Review (2) Fast
Track (3) Accelerated Approval Pathway and (4) Breakthrough Therapy.

Priority Review

Priority Review was authorized
in 1992 by the Prescription Drug User Fee Act (PDUFA) which created the two-tiered FDA drug review system (standard v. priority). This
pathway shortens application review from 10 months (standard) to 6 months (priority). The FDA determines if a drug receives a standard
or priority review, although sponsors may request a priority review. Priority review is granted if a new drug would result in a significant
improvement in safety and effectiveness compared to existing therapies.

Fast Track

Drugs for the treatment of
serious conditions that address an unmet medical need receive an expedited review. The purpose of this pathway is to get important new
drugs to patent earlier, for conditions such as Alzheimer’s disease, epilepsy, depression, and multiple sclerosis. Any drug being
developed to treat or prevent a condition with no current therapy is prioritized. If there are available therapies, the new drug must:

| 1. | Show superior efficacy;                                               |
| 2. | Avoid serious side effects of the available therapy;                  |
| 3. | Decrease clinically significant toxicity of an available therapy; and |
| 4. | Address an emerging or anticipated public health need.                |

Fast Track designation should
come at the time of submission and be requested by the manufacturer, although it can be requested at any time in the approval process.
Once in the Fast Track pathway, there are more frequent meetings with the FDA to discuss the development plan and appropriate data needed
to support drug approval. Drugs in the Fast Track pathway are also eligible for accelerated approval and priority review if relevant criteria
are met.

Accelerated Approval Pathway

Authorized in 1992 and updated
in 2012, this pathway is applied to new therapies that treat serious or life- threatening conditions for