Company: SXTPW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003343
Chunk: 44

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 44
---
 serious and unexpected suspected adverse reactions; findings from
other studies or animal or in vitro testing that suggest a significant risk in humans exposed to the drug; and any clinically
important increase in the case of a serious suspected adverse reaction over that listed in the protocol or investigator brochure. Phase
1, Phase 2 and Phase 3 clinical trials may not be completed successfully within any specified period, or at all. Furthermore, the FDA
or the sponsor may suspend or terminate a clinical trial at any time on various grounds, including a finding that the research subjects
are being exposed to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution,
or an institution it represents, if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the
drug has been associated with unexpected serious harm to patients. The FDA will typically inspect one or more clinical sites to assure
compliance with GCP and the integrity of the clinical data submitted.

Concurrent with clinical trials, companies often
complete additional animal studies and must also develop additional information about the chemistry and physical characteristics of the
drug as well as finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements. The manufacturing
process must be capable of consistently producing quality batches of the drug candidate and, among other things, must develop methods
for testing the identity, strength, quality, purity, and potency of the final drug. Additionally, appropriate packaging must be selected
and tested and stability studies must be conducted to demonstrate that the drug candidate does not undergo unacceptable deterioration
over its shelf life.

Submission of an NDA to the FDA 

Assuming successful completion of required clinical
testing and other requirements, the results of the preclinical studies and clinical trials, together with detailed information relating
to the product’s chemistry, manufacture, controls and proposed labeling, among other things, are submitted to the FDA as part of
an NDA requesting approval to market the drug product for one or more indications. Under federal law, the submission of most NDAs is
additionally subject to an application user fee and the sponsor of an approved NDA is also subject to annual product and establishment
user fees. These fees are typically increased annually. Certain exceptions and waivers are available for some of these fees, such as
an exception from the application fee for products with orphan designation and a waiver for certain small businesses, an exception from
the establishment fee when the establishment does not engage in manufacturing the product during a particular