Company: TVRD
Filing Date: 2025-10-20
Form Type: S-1/A
Source: 0001104659-25-100896
Chunk: 208

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-10-20
Form: S-1/A
Chunk 208
---
 of extensive nonclinical laboratory and animal tests, which must be conducted in accordance with applicable regulations, including good laboratory practices and applicable requirements for the humane use of laboratory animals or other applicable regulations;

•

submission to the FDA of an IND application, which must become effective before clinical trials may begin and must be updated annually;

•

approval by an independent institutional review board (“IRB”) or ethics committee for each clinical site or centrally before each clinical trial may be initiated;

•

performance of adequate and well-controlled human clinical trials to establish the safety and efficacy of the proposed drug candidate for its intended use, performed in accordance with Good Clinical

<div align='center'>129</div>

TABLE OF CONTENTS

Practices (“GCPs”) requirements to establish the safety and efficacy of the product candidate for each proposed indication;

•

submission to the FDA of an NDA after completion of all pivotal clinical studies that include substantial evidence of safety and efficacy of the drug from analytical studies and from results of nonclinical testing and clinical trials and payment of user fees;

•

determination by the FDA within 60 days of its receipt of an NDA to file the application for review;

•

satisfactory completion of a pre-approval inspection of manufacturing facilities and selected clinical investigators for their compliance with current Good Manufacturing Practices (“cGMPs”) and GCPs;

•

satisfactory completion of FDA audits of clinical trial sites to ensure compliance with GCPs and the integrity of the clinical data;

•

satisfactory completion of an FDA advisory committee review, if applicable;

•

FDA review and approval of an NDA to permit commercial marketing for particular indications for use in the United States; and

•

compliance with any post-approval requirements, including the potential requirement to implement a Risk Evaluation and Mitigation Strategy (“REMS”), and the potential requirement to conduct post-approval studies.

•

The testing and approval process requires substantial time, effort and financial resources.

#### Preclinical Studies
Preclinical studies include laboratory evaluation of drug substance chemistry, pharmacology, toxicity and drug product formulation, as well as animal studies to assess potential safety and efficacy. Prior to commencing the first clinical trial with a drug candidate, a sponsor must submit the results of the preclinical tests and preclinical literature, together with manufacturing information, analytical data and any available clinical data or literature, among other required information, to the FDA as part of an IND. An IND is a request for authorization from the FDA to administer an investigational new drug or biological product to humans. Some preclinical studies may