Company: NCEL
Filing Date: 2025-06-09
Form Type: F-4/A
Source: 0001213900-25-052354
Chunk: 396

Company: NewcelX Ltd.
Filing Date: 2025-06-09
Form: F-4/A
Chunk 396
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 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 part of the IND. Some pre -clinicaltesting may continue after the IND is submitted. In addition to including the results of the pre -clinicalstudies, the IND will also include a clinical trial protocol detailing, among other things, the objectives of the clinical trial, the parameters to be used in monitoring safety and, depending on the phase of the study, the effectiveness criteria to be evaluated. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30 -daytime period, places the IND on clinical hold. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before clinical trials can begin. A clinical hold may occur at any time during the life of an IND, due to safety concerns or non -compliance, and may affect one or more specific studies or all studies conducted under the IND. 222 All clinical trials must be conducted under the supervision of one or more qualified investigators in accordance with the FDA’s GCP regulations. These regulations include the requirement that all research subjects provide informed consent. Further, an IRB