Company: NCEL
Filing Date: 2025-07-29
Form Type: F-4/A
Source: 0001213900-25-068765
Chunk: 160

Company: NewcelX Ltd.
Filing Date: 2025-07-29
Form: F-4/A
Chunk 160
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 each of its studies is conducted in accordance with the applicable protocol, legal, regulatory and scientific standards and its reliance on the CROs does not relieve it of its regulatory responsibilities. NLS and its CROs and other vendors are required to comply with current cGMP, Good Clinical Practices, or GCP, quality system requirements, or QSR, and Good Laboratory Practices, or GLP, which are regulations and guidelines enforced by the FDA, the Competent Authorities of the Member States of the European Economic Area, and comparable foreign regulatory authorities for all of its product candidates in clinical development. Regulatory authorities enforce these regulations through periodic inspections of study sponsors, principal investigators, study sites and other contractors. If NLS or any of its CROs or vendors fail to comply with applicable regulations, the clinical data generated in its clinical studies may be deemed unreliable and the FDA, EMA or comparable foreign regulatory authorities may require it to perform additional clinical studies before approving its marketing applications. NLS cannot assure you that upon inspection by a given regulatory authority, such regulatory authority will determine that any of its clinical studies comply with GCP regulations. In addition, its clinical studies must be conducted with product candidates which are produced under cGMP regulations. Its failure to comply with these regulations may require it to repeat clinical studies, which would delay the regulatory approval process. NLS has no manufacturing capacity and anticipates reliance on third-party manufacturers for its products. NLS does not currently operate manufacturing facilities for clinical production of Quilience and/or Nolazol. NLS does not intend to develop facilities for the manufacturing of products for clinical trials or commercial purposes in the foreseeable future. NLS will rely on third -partymanufacturers to produce bulk drug products required for its clinical trials and commercial sales, if any. NLS plans to continue to rely upon contract manufacturers and, potentially, collaboration partners to manufacture commercial quantities of its drug product candidates if and when approved for marketing by the applicable regulatory authorities. Its contract manufacturers have not completed process validation for the drug substance manufacturing process. Process validation involves a series of activities taking place over the lifecycle of the product and process. If its contract manufacturers are not approved by the FDA, or other regulatory bodies, its commercial supply of drug substance will be significantly delayed and may result in significant additional costs. If the FDA does not consider the result of the process validation or required testing to be satisfactory, regulatory approval and/or commercial supply after launch may be delayed. The FDA and similar foreign regulatory bodies may also implement new requirements, or