Company: SXTPW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003343
Chunk: 47

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 47
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 no longer supported by
data emerging in the clinical trial process.

Second, a product may be designated as a breakthrough
therapy if it is intended, either alone or in combination with one or more other products, to treat a serious or life-threatening disease
or condition and preliminary clinical evidence indicates that the product may demonstrate substantial improvement over existing therapies
on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. The FDA
may take certain actions with respect to breakthrough therapies, including holding meetings with the sponsor throughout the development
process; providing timely advice to the product sponsor regarding development and approval; involving more senior staff in the review
process; assigning a cross-disciplinary project lead for the review team; and taking other steps to design the clinical trials in an
efficient manner.

23

Third, the FDA may designate a product for priority
review if it is a product that treats a serious condition and, if approved, would provide a significant improvement in safety or effectiveness.
The FDA determines, on a case-by-case basis, whether the proposed product represents a significant improvement when compared with other
available therapies. Significant improvement may be illustrated by evidence of increased effectiveness in the treatment of a condition,
elimination or substantial reduction of a treatment-limiting product reaction, documented enhancement of patient compliance that may
lead to improvement in serious outcomes, and evidence of safety and effectiveness in a new subpopulation. A priority designation is intended
to direct overall attention and resources to the evaluation of such applications, and to shorten the FDA’s goal for taking action
on a marketing application from ten months to six months.

Tropical Disease PRVs

The Tropical Disease Priority Review Voucher
(“PRV”) program was created by Congress under the Food and Drug Administration Amendments Act of 2007 (“FDAAA”)
in order to encourage innovation and public access to new medicines. Pursuant to Section 1102 of FDAAA, which amended section 524 of
the Federal Food, Drug, and Cosmetic Act (“FFDCA”), along with later amendments, the FDA must award a PRV to certain applicants
that obtain an approved NDA to treat certain tropical diseases. Congress later expanded the scope of diseases that were eligible for
a PRV (e.g., a PRV for obtaining approval for a drug to treat rare pediatric diseases). A PRV entitles the holder of the voucher to designate
a different drug application as qualifying for priority review from FDA. When a drug application is designated for priority review through
use of a