Company: NCEL
Filing Date: 2025-09-03
Form Type: F-4/A
Source: 0001213900-25-084157
Chunk: 141

Company: NewcelX Ltd.
Filing Date: 2025-09-03
Form: F-4/A
Chunk 141
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 or facilities of third -partymanufacturers with which we enter into agreements for clinical and commercial supplies; •changes in approval policies or the adoption of new regulations by such regulators; and •NLS may be unable to be granted a PIP deferral which we intend to request from the EMA for delayed clinical trials and subsequent approval in children; this may delay its clinical trial program or approvals for adults, or we may have successful clinical trial results for adults but not children (if NLS were required to conduct pediatric studies prior to the receipt of an NDA or MAA for use of its product candidates in adults), or vice versa. Before NLS can submit an NDA to the FDA, NLS must conduct pivotal trials, in addition to human pharmacokinetic and bioavailability studies, that will be substantially broader than its Phase 2 trial for Nolazol and or Quilience. An NDA must be supported by extensive clinical and pre -clinicaldata, as well as extensive information regarding chemistry, manufacturing and controls to demonstrate the safety and effectiveness of the applicable product candidate. The number and types of pre -clinicalstudies and clinical trials that will be required varies depending on the product candidate, the disease or condition that the product candidate is designed to target and the regulations applicable to any particular product candidate. Obtaining approval of an NDA is a lengthy, expensive and uncertain process, and NLS may not be successful in obtaining approval. 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