Company: NCEL
Filing Date: 2025-09-10
Form Type: 424B3
Source: 0001213900-25-086600
Chunk: 142

Company: NewcelX Ltd.
Filing Date: 2025-09-10
Form: 424B3
Chunk 142
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 requested that companies enter into consent decrees, corporate integrity agreements or permanent injunctions under which specified promotional conduct must be changed or curtailed. If NLS cannot successfully manage the promotion of its product candidates, if approved, NLS could become subject to significant liability, which would materially adversely affect its business and financial condition. Obtaining and maintaining regulatory approval of its product candidates in one jurisdiction does not mean that NLS will be successful in obtaining regulatory approval of its product candidates in other jurisdictions. Its failure to obtain regulatory approval in foreign jurisdictions would prevent its product candidates from being marketed abroad, and any approval NLS is granted for its product candidates in the United States would not assure approval of product candidates in foreign jurisdictions. In order to market any products outside of the United States, NLS must establish and comply with numerous and varying regulatory requirements of other 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