Company: NCEL
Filing Date: 2025-07-29
Form Type: F-4/A
Source: 0001213900-25-068765
Chunk: 142

Company: NewcelX Ltd.
Filing Date: 2025-07-29
Form: F-4/A
Chunk 142
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. Even if NLS obtains FDA, EMA or other regulatory approval for Quilience and/or Nolazol, the approval might contain significant limitations related to use restrictions for certain age groups, warnings, precautions or contraindications, or may be subject to significant post -marketingstudies or risk mitigation requirements. In addition, even if NLS obtains an MAA from the EMA for the use of Quilience in adults, there can be no guarantee that NLS will receive an MAA for Quilience for the use in children. If NLS is unable to successfully commercialize Quilience and/or Nolazol, NLS may be forced to cease operations. The results of clinical trials conducted at clinical sites outside the United States may not be accepted by the FDA and the results of clinical trials conducted at clinical sites in the United States may not be accepted by international regulatory authorities. NLS is conducting its Phase 2 clinical trials in the United States. In future, NLS is planning to conduct Phase 2b and or Phase 3 clinical trials in the United States and the EU. Although the FDA may accept data from clinical trials conducted outside the United States, acceptance of this data is subject to certain conditions imposed by the FDA. For example, the clinical trial must be well -designedand conducted and performed by qualified investigators in accordance with ethical principles such as IRB or ethics committee approval and informed consent. The study population must also adequately represent the U.S. population, and the data must be applicable to the U.S. population and U.S. medical practice in ways that the FDA deems clinically meaningful. Generally, the subject population for any clinical trials conducted outside of the United States must be representative of the U.S. population. In addition, while these clinical trials are subject to the applicable local laws, FDA acceptance of the data will be dependent upon its determination that the trials were conducted consistent with all applicable U.S. laws and regulations. There can be no assurance that the FDA or international regulatory authorities will accept data from trials conducted outside of the United States or inside the United States, as the case may be, as adequate support of a marketing application. If the FDA or international regulatory authorities do not accept the data from sites in its globally conducted clinical trials, it would likely result in the need for additional trials, which would be costly and time -consumingand could delay or permanently halt the development of one or more of its product candidates. NLS’s product candidates may cause undesirable side effects or