Company: SXTPW
Filing Date: 2025-03-27
Form Type: S-1/A
Source: 0001013762-25-003353
Chunk: 5

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-03-27
Form: S-1/A
Chunk 5
---
 viral disease occurring in tropical and subtropical areas. “Ethics Committee” a stand-alone or institutional committee responsible for ensuring clinical trials are conducted ethically, and from whom permission is required for a clinical trial to proceed. “EUA” means Emergency Use Authorization. “FDA” refers to the U.S. Food and Drug Administration. “G6PD” means glucose-6-phosphate dehydrogenase. “GMP” means Good Manufacturing Practices. “IND” means investigational new drug application. “Kodatef” is the brand name of Arakoda outside the United States. Kodatef has been approved for use in Australia by the Therapeutic Goods Administration. “Legacy Studies” is a reference to the collection of clinical and non-clinical studies involving Tafenoquine, which were conducted by the U.S. Army prior to 2014, and which were included in the new drug application submitted by 60P to the FDA in 2018. Some of those Legacy Studies are described in the account of the Army development program published by Zottig et. al. “Mode of Action” is the process by which an anti-infective or other pharmaceutical product is known or suspected to affect a disease process. This process is different for each drug and may or may not be known at the time of FDA approval. “Named-patient” use of a drug refers to the prescription by a physician of a drug to one of their patients in a jurisdiction in which the prescribed drug has not received marketing authorization, but is believed by said physician to be safe and medically necessary. Also, sometimes referred to as “compassionate use.” “NIH” means the National Institutes of Health. “PDUFA” means The Prescription Drug User Fee Act. “PMA” means Premarket Approval by the FDA. “Primaquine” is the FDA-approved antimalarial from which Tafenoquine is chemically derived. “ P. vivax” is an abbreviation for Plasmodium vivax, one of the two most important malaria parasites, characterized by its ability to relapse utilizing a dormant life cycle stage that persists in the human liver following a bite from an infected mosquito. “RSV” means respiratory syncytial virus, which is a common respiratory virus that usually causes cold-like symptoms. “Repositioned Molecule” is one which was approved by the FDA or other regulatory authorities to treat one disease, and is being developed for a new disease. “Spp” is shorthand use to refer