Company: NCEL
Filing Date: 2025-07-18
Form Type: F-4/A
Source: 0001213900-25-065783
Chunk: 141

Company: NewcelX Ltd.
Filing Date: 2025-07-18
Form: F-4/A
Chunk 141
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. Depending on the extent of these or any other studies, approval of any applications that NLS submits may be delayed by several years, or may require it to expend more resources than NLS has available. It is also possible that additional studies, if performed and completed, may not be considered sufficient by the FDA to approve the NDA. If any of these outcomes occur, NLS would not receive approval for Quilience or Nolazol at such time, if any, when NLS seeks FDA approval. NLS may face similar risks with respect to obtaining regulatory approval from the EMA for Quilience, and for Nolazol, at such 33 time, if any, when NLS seeks EMA approval. The risks that NLS faces in obtaining applicable approvals from the FDA and EMA for Quilience and/or Nolazol or any other product candidate that NLS may seek to develop, may also exist with other regulatory authorities, such as those in Latin America. 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