Company: NCEL
Filing Date: 2025-09-03
Form Type: F-4/A
Source: 0001213900-25-084157
Chunk: 150

Company: NewcelX Ltd.
Filing Date: 2025-09-03
Form: F-4/A
Chunk 150
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 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 the Orphan Drug Act, the FDA may designate a product as an orphan drug if it is a drug intended to treat a rare disease or condition, which is generally defined as a patient population of fewer than 200,000 individuals in the United States or a patient population of greater than 200,000 individuals in the United States, but for which there is no reasonable expectation that the cost of developing the drug will be recovered from sales in the United States. In the EU, the European Commission grants orphan drug designation to promote the development of products that are intended for the diagnosis, prevention or treatment of a life -threateningor chronically debilitating condition affecting not more than five in 10,000 persons in the EU community. Additionally, designation 38 is granted for products intended for the diagnosis, prevention or treatment of a life -threatening, seriously debilitating or serious and chronic condition and when, without incentives, it is unlikely that sales of the drug in the EU would be sufficient to justify the necessary investment in developing the drug. The FDA granted orphan drug designation to mazindol for the treatment