Company: NCEL
Filing Date: 2025-09-10
Form Type: 424B3
Source: 0001213900-25-086600
Chunk: 422

Company: NewcelX Ltd.
Filing Date: 2025-09-10
Form: 424B3
Chunk 422
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 or MHRA through its authorization procedures before they may be legally marketed in the UK. Any product candidate will be subject to similar requirements in other countries prior to marketing in those countries. The process of obtaining regulatory approvals and the subsequent compliance with applicable federal, state, local and foreign statutes and regulations require the expenditure of substantial time and financial resources.

226 United States Government Regulation NDA Approval Processes In the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act, or the FDCA, and implementing regulations and guidance documents. Failure to comply with the applicable U.S. requirements at any time during the product development process or approval process, or after approval, may subject an applicant to administrative or judicial sanctions, any of which could have a material adverse effect on Kadimastem. These sanctions could include refusal to approve pending applications, withdrawal of an approval, imposition of a clinical hold, issuance of warning letters, product seizures, total or partial suspension of production or distribution, injunctions, fines, disgorgement, and civil or criminal penalties. The process required by the FDA before a drug may be marketed in the United States generally involves the following: •completion of pre -clinicallaboratory tests, animal studies and formulation studies conducted according to GLPs, or other applicable regulations; •submission to the FDA of an IND application, which must become effective before human clinical trials may begin; •performance of adequate and well -controlledhuman clinical trials according to GCPs, to establish the safety and efficacy of the proposed drug for its intended use; •submission to the FDA of an NDA; •satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the product is produced to assess compliance with cGMPs to assure that the facilities, methods and controls are adequate to preserve the drug’s identity, strength, quality and purity; •satisfactory completion of FDA inspections of clinical sites and GLP toxicology studies; and •FDA review and approval of the NDA. The testing and approval process requires substantial time, effort and financial resources, and Kadimastem cannot be certain that any approvals for a product candidate will be granted on a timely basis, if at all. Once a product candidate is identified for development, it enters the pre -clinicaltesting stage. Pre -clinicaltests include laboratory evaluations of product chemistry, toxicity and formulation, as well as animal studies. An IND sponsor must submit the results of the pre -clinicaltests, together with manufacturing information and analytical data, to the FDA as