Company: NCEL
Filing Date: 2025-06-23
Form Type: F-4/A
Source: 0001213900-25-056787
Chunk: 112

Company: NewcelX Ltd.
Filing Date: 2025-06-23
Form: F-4/A
Chunk 112
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. The FDA review processes can take years to complete and approval is never guaranteed. In this respect, NLS will also need to agree on a protocol with the FDA for the pivotal trials before commencing those trials. Pivotal trials frequently produce unsatisfactory results even though prior clinical trials were successful. Therefore, the results of the additional trials that NLS conduct may or may not be successful. The FDA may suspend all clinical trials or require that NLS conduct additional clinical, nonclinical, manufacturing validation or drug product quality studies and submit those data before it will consider or reconsider the NDA. 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 32 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