Company: NCEL
Filing Date: 2025-09-10
Form Type: 424B3
Source: 0001213900-25-086600
Chunk: 217

Company: NewcelX Ltd.
Filing Date: 2025-09-10
Form: 424B3
Chunk 217
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 perceived advantage over alternative treatment methods, if any; •adverse events involving Kadimastem’s cell therapy product candidates or the products or product candidates of others that are cell -based; and •the cost of Kadimastem’s products and the reimbursement policies of government and private third party payers. If the health care community does not accept Kadimastem’s potential products for any of the foregoing reasons, or for any other reason, it could affect its sales, having a material adverse effect on Kadimastem’s business, financial condition and results of operations. Even if Kadimastem obtains regulatory approval for a product candidate, its products will remain subject to ongoing regulatory oversight. Even if Kadimastem obtains any regulatory approval for its product candidates, it will be subject to ongoing regulatory requirements for manufacturing (including manufacturing sites), labeling, packaging, storage, advertising, promotion, sampling, record -keepingand submission of safety and other post -marketinformation. Any regulatory approvals that 80 it receives for its product candidates also may be subject to a REMS, limitations on the approved indicated uses for which the product may be marketed or to the conditions of approval or contain requirements for potentially costly post -marketingmanufacturing site improvements and testing, including Phase 4 clinical trials, and surveillance to monitor the quality, safety and efficacy of the product. The holder of an approved BLA also must submit new or supplemental applications and obtain FDA approval for certain changes to the approved product, manufacturing facility, product labeling or manufacturing process. Advertising and promotional materials must comply with FDA rules and are subject to FDA review, in addition to other potentially applicable federal and state laws. In addition, product manufacturers and their facilities are subject to payment of user fees and continual review and periodic inspections by the FDA and other regulatory authorities for compliance with current good manufacturing practices, or cGMP, requirements and adherence to commitments made in the BLA or foreign marketing application. If Kadimastem, or a regulatory authority, discover previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with the facility where the product is manufactured or disagrees with the promotion, marketing or labeling of that product, a regulatory authority may impose restrictions relative to that product, the manufacturing facility or Kadimastem, including requiring recall or withdrawal of the product from the market or suspension of manufacturing. If Kadimastem fails to comply with applicable regulatory requirements, a regulatory authority may: •issue an untitled letter or warning letter that Kadimastem