Company: NCEL
Filing Date: 2025-06-23
Form Type: F-4/A
Source: 0001213900-25-056787
Chunk: 120

Company: NewcelX Ltd.
Filing Date: 2025-06-23
Form: F-4/A
Chunk 120
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 countries regarding clinical trial design, safety and efficacy. The research, testing, manufacturing, labeling, approval, sale, marketing and distribution of drugs is subject to extensive regulation by the FDA in the United States and other regulatory authorities in other countries. These regulations differ from country to country. Even if NLS obtains and maintains regulatory approval of its product candidates in one jurisdiction, such approval does not guarantee that NLS will be able to obtain or maintain regulatory approval in any other jurisdiction, but a failure or delay in obtaining regulatory approval in one jurisdiction may have a negative effect on the regulatory approval process in others. For example, even if the FDA grants marketing approval of a product candidate, comparable regulatory authorities in foreign jurisdictions must also approve the manufacturing, marketing and promotion of the product candidate in those countries. Approval procedures vary among jurisdictions and can involve requirements and administrative review periods different from those in the United States, including additional pre -clinicalstudies or clinical trials as investigations conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions. In many jurisdictions outside the United States, a product candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction. In some cases, the price that NLS intends to charge for its products is also subject to approval. These regulatory procedures can result in substantial delays in such countries. In other countries, product approval depends on showing superiority to an approved alternative therapy. This can result in significant expenses for conducting complex clinical trials. Finally, NLS does not have any products approved for sale in any jurisdiction, including international markets, and NLS does not have experience in obtaining regulatory approval. If we, or any third parties with whom NLS work, fail to comply with regulatory requirements in the United States or international markets or to obtain and maintain required approvals or if regulatory approvals in international markets are delayed, its target market may be reduced and its ability to realize the full market potential of its products will likely be harmed. The inability to meet continuously evolving regulatory standards for approval may result in its failing to obtain regulatory approval to market its current product candidates, which could significantly harm its business, results of operations and prospects. NLS may be unable to obtain or maintain orphan drug designation for its product candidates and, even if NLS obtains such designation, NLS may not be able to realize the benefits of such designation, including potential marketing exclusivity of its product candidates, if approved. Regulatory authorities in some jurisdictions, including the United States and EU, may designate drugs for relatively small patient populations as “orphan drugs.” Under