Company: SXTPW
Filing Date: 2025-02-14
Form Type: S-1
Source: 0001213900-25-014334
Chunk: 5

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-02-14
Form: S-1
Chunk 5
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 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 to multiple species of organisms in a particular genus. Thus, Candidaspp refers collectively to Candida auris, Candida albicansand other Candidaspecies. iii “Tafenoquine” is the shortened name of the active ingredient of Arakoda and Kodatef, Tafenoquine succinate. “TGA” is the Therapeutic Goods Administration, the Australian equivalent of the FDA. “TMPRSS2” means transmembrane protease, serine 2, which is an enzyme that in humans is encoded by the TMPRSS2 gene, and belongs to the TMPRSS family of proteins, whose members are transmembrane proteins which have a serine protease activity. “Zika” means a mosquito-borne viral disease occurring in tropical