Company: NCEL
Filing Date: 2025-07-29
Form Type: F-4/A
Source: 0001213900-25-068765
Chunk: 443

Company: NewcelX Ltd.
Filing Date: 2025-07-29
Form: F-4/A
Chunk 443
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 eligibility to obtain approvals from the FDA, or exclusion from participation in government contracting, healthcare reimbursement or other government programs, including Medicare and Medicaid. Other Countries In addition to regulations in the United States, the EU, the UK and Israel, Kadimastem is subject to a variety of other regulations governing clinical trials and commercial sales and distribution of drugs in other countries. Whether or not a product candidate receive approval from the FDA, approval of such product candidates must be obtained by the comparable regulatory authorities of countries other than the United States before Kadimastem can commence clinical trials or marketing of the product in those countries. The approval process varies from jurisdiction to jurisdiction, and the time may be longer or shorter than that required for FDA approval. The requirements governing the conduct of clinical trials and product licensing vary greatly from country to country. The requirements that Kadimastem must satisfy to obtain regulatory approval by government agencies in other countries prior to commercialization of any other product candidate in such countries can be rigorous, costly and uncertain. In the European countries, UK, Canada and Australia, regulatory requirements and approval processes are similar in principle to those in the United States. Additionally, depending on the type of drug for which approval is sought, there are currently two potential tracks for marketing approval in the European countries: mutual recognition and the centralized procedure. These review mechanisms may ultimately lead to approval in all EU countries, but each method grants all participating countries some decision -makingauthority in product approval. The UK has a separate review period but for a transitional period until December 31, 2022, may rely on approvals under the EU mutual recognition and/or centralized procedure. Foreign governments also have stringent post -approvalrequirements including those relating to manufacture, labeling, reporting, record keeping and marketing. Failure to substantially comply with these on -goingrequirements could lead to government action against the product, Kadimastem and/or Kadimastem’s representatives. Company Information Kadimastem was established as an Israeli company on October 6, 2008. Kadimastem began trading on the TASE in June 2013. 233 NLS’S MANAGEMENT’S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS The following discussion and analysis should be read in conjunction with NLS’s financial statements and related notes included elsewhere in this proxy statement/prospectus. This discussion and analysis contains forward -looking statements based upon current expectations that involve risks and uncertainties. NLS’s actual results and the timing of selected events could differ materially from those anticipated