Company: SXTPW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003343
Chunk: 41

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 41
---
 assess the safety and activity of the drug for initial testing in humans and to establish
a rationale for therapeutic use. The conduct of preclinical studies is subject to federal regulations and requirements, including GLP
regulations. The results of the preclinical tests, together with manufacturing information, analytical data, any available clinical data
or literature and plans for clinical trials, among other things, are submitted to the FDA as part of an IND. Some long-term preclinical
testing, such as animal tests of reproductive adverse events and carcinogenicity, may continue after the IND is submitted.

Companies usually must complete some long-term
preclinical testing, such as animal tests of reproductive adverse events and carcinogenicity, and must also develop additional information
about the chemistry and physical characteristics of the investigational product and 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 product candidate and, among other things, the manufacturer must develop methods for testing the identity, strength, quality
and purity of the final product. Additionally, appropriate packaging must be selected and tested, and stability studies must be conducted
to demonstrate that the product candidate does not undergo unacceptable deterioration over its shelf life.

The IND and IRB Processes

An IND is an exemption from the FDCA that allows
an unapproved drug to be shipped in interstate commerce for use in an investigational clinical trial and a request for FDA authorization
to administer an investigational drug to humans. Such authorization must be secured prior to interstate shipment and administration of
any new drug that is not the subject of an approved NDA. In support of a request for an IND, applicants must submit a protocol for each
clinical trial and any subsequent protocol amendments must be submitted to the FDA as part of the IND. In addition, the results of the
preclinical tests, together with manufacturing information, analytical data, any available clinical data or literature and plans for
clinical trials, among other things, are submitted to the FDA as part of an IND. The FDA requires a 30-day waiting period after the filing
of each IND before clinical trials may begin. This waiting period is designed to allow the FDA to review the IND to determine whether
human research subjects will be exposed to unreasonable health risks. At any time during this 30-day period, the FDA may raise concerns
or questions about the conduct of the trials as outlined in the IND and impose a clinical hold. In this case, the IND