Company: OSRH
Filing Date: 2025-01-29
Form Type: S-4/A
Source: 0001213900-25-007923
Chunk: 428

Company: OSR Holdings, Inc.
Filing Date: 2025-01-29
Form: S-4/A
Chunk 428
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 data through an onsite inspection if deemed necessary. Clinical trials, generally, are conducted in three sequential phases, known as Phase 1, Phase 2 and Phase 3, and may overlap. • Phase 1clinical trials generally involve a small number of healthy volunteers or disease -affectedpatients who are initially exposed to a single dose and then multiple doses of the product candidate. The primary purpose of these clinical trials is to assess the metabolism, pharmacologic action, side -effecttolerability and safety of the product candidate. • Phase 2clinical trials involve studies in disease -affectedpatients to evaluate proof of concept and/or determine the dose required to produce the desired benefits. At the same time, safety and further pharmacokinetic and pharmacodynamic information is collected, possible adverse effects and safety risks are identified and a preliminary evaluation of efficacy is conducted. • Phase 3clinical trials generally involve a larger number of patients at multiple geographically dispersed clinical trial sites and are designed to provide the data necessary to demonstrate the effectiveness of the product for its intended use, its safety in use and to establish the overall benefit/risk relationship of the product candidate and provide an adequate basis for approval and product labeling. 270 Post -approvaltrials, sometimes referred to as Phase 4 clinical trials, may be conducted after initial marketing approval. These trials are conducted to gain additional experience from the treatment of patients in the intended therapeutic indication and are commonly intended to generate additional safety data regarding use of the product in a clinical setting. In certain instances, the FDA may mandate the performance of Phase 4 clinical trials as a condition of approval of an NDA or BLA. Failure to exhibit due diligence with regard to conducting Phase 4 clinical trials, if required, could result in withdrawal of conditional approval for product candidates. The FDA requires annual progress reports on the results of clinical trials as well as written IND safety reports promptly after the occurrence of serious and unexpected suspected adverse events in the trial or from other studies (animal or in vitrotesting) that suggest a significant risk for humans. The report must include any clinically important increase in the rate of a serious suspected adverse reaction over that listed in the protocol or investigator brochure. The sponsor must also notify the FDA of any unexpected fatal or life -threateningsuspected adverse reaction as soon as possible but in no case later than seven calendar days after the sponsor’s initial receipt of such information. It is possible that Phase 1, Phase 2, Phase 3 and other types of clinical trials may not be completed successfully, if at