Company: TVRD
Filing Date: 2025-01-27
Form Type: S-4/A
Source: 0001104659-25-006050
Chunk: 491

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-01-27
Form: S-4/A
Chunk 491
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 approved for sale. If and when its product candidates receive marketing approval, it intends to commercialize them on its own, or jointly with a partner, in the United States and potentially in other geographies. Tvardi will continually evaluate the economics of commercializing its product candidates versus other strategic commercialization arrangements. Manufacturing Tvardi does not own or operate, and currently has no plans to establish, any manufacturing facilities. Tvardi has engaged, and expects to continue to rely on, well-established third-party Contract Development and Manufacturing Organizations (CDMOs), to supply its product candidates for use in its preclinical studies and clinical trials. Should any of these CDMOs become unavailable to Tvardi for any reason, it believes that there are a number of potential replacements, although Tvardi may incur some delay in identifying and qualifying such replacements. Additionally, it intends to rely on third-party CDMOs for commercial manufacturing, if its product candidates receive marketing approval. As its lead product candidates advance through development, it expects to enter into longer-term commercial supply agreements to fulfill and secure its production needs. Additionally, to adequately meet its projected commercial manufacturing needs, its CDMOs will need to scale-up production, or it will need to secure additional suppliers. Processes for producing drug substances and drug product for commercial supply are currently being developed, with the goal of achieving reliable, reproducible and cost-effective production. Government Regulation The FDA and comparable regulatory agencies in state and local jurisdictions and in foreign countries impose substantial requirements upon the clinical development, manufacture and marketing of pharmaceutical and diagnostic products. These agencies and other federal, state and local entities regulate research and development activities and the testing, manufacture, quality control, safety, effectiveness, labeling, storage, packaging, recordkeeping, tracking, approval, import, export, distribution, advertising and promotion of drug products. U.S. Government Regulation of Drug Products In the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act (the FDCA), and its implementing regulations. The process of obtaining regulatory approvals and the subsequent compliance with applicable federal, state, local and foreign statutes and regulations requires the expenditure of substantial time and financial resources. Failure to comply with the applicable U.S. requirements at any time during the product development process, approval process or after approval, may subject an applicant to a variety of administrative or judicial sanctions, such as the FDA’s refusal to approve a pending new drug application (NDA), withdrawal of an approval, imposition of a clinical hold, issuance of untitled or warning