Company: NCEL
Filing Date: 2025-09-03
Form Type: F-4/A
Source: 0001213900-25-084157
Chunk: 149

Company: NewcelX Ltd.
Filing Date: 2025-09-03
Form: F-4/A
Chunk 149
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, if approved. In particular, while the FDA 37 permits the dissemination of truthful and non -misleadinginformation about an approved product, a manufacturer may not promote a product for uses that are not approved by the FDA or such other regulatory agencies as reflected in the product’s approved labeling. If NLS is found to have promoted such off -labeluses, NLS may become subject to significant liability. The federal government has levied large civil and criminal fines against companies for alleged improper promotion of off -labeluse and has enjoined several companies from engaging in off -labelpromotion. The FDA has also 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