Company: OSRH
Filing Date: 2025-01-24
Form Type: S-4/A
Source: 0001213900-25-006139
Chunk: 184

Company: OSR Holdings, Inc.
Filing Date: 2025-01-24
Form: S-4/A
Chunk 184
---
 necessary approvals from regulators to commence a clinical trial, or a suspension or termination of a clinical trial once commenced; •conditions imposed by the FDA or comparable foreign authorities regarding the scope or design of our clinical trials; •delays in enrolling participants in clinical trials; •high drop -outrates of participants from clinical trials; •inadequate supply or quality of product candidates or other materials necessary for the conduct of our clinical trials; •greater than anticipated clinical trial costs; •inability to compete with other therapies; 98 •poor efficacy of our product candidates during clinical trials; •unfavorable FDA or other regulatory agency inspection and review of a clinical trial site; •failure of our third -partycontractors or investigators to comply with regulatory requirements or otherwise meet their contractual obligations in a timely manner, or at all; •delays related to the impact of recessions, man -madeand/or natural disasters, pandemics, and/or any other such events; •delays and changes in regulatory requirements, policy and guidelines, including the imposition of additional regulatory oversight around clinical testing generally or with respect to our technology in particular; or •varying interpretations of data by the FDA and similar foreign regulatory agencies. We do not have complete control over many of these factors, including certain aspects of clinical development and the regulatory submission process, potential threats to our intellectual property rights and our manufacturing, marketing, distribution and sales efforts or that of any future collaborator. We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development of any of our product candidates, which may adversely impact our results of operations and financial condition. We may experience delays in initiating or completing clinical trials. Clinical trials can be delayed or terminated for a variety of reasons, including: •regulators or institutional review boards (“ IRB”) or ethics committees may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site; •the FDA or other comparable regulatory authorities may disagree with our clinical trial design, including with respect to dosing levels administered in our planned clinical trials, which may delay or prevent us from initiating our clinical trials with our originally intended trial design; •we may experience delays in reaching, or fail to reach, agreement on acceptable terms with prospective trial sites and prospective contract research organizations, or CROs, which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; •The number of participants required for clinical trials of any product candidates may be