Company: NCEL
Filing Date: 2025-07-29
Form Type: F-4/A
Source: 0001213900-25-068765
Chunk: 147

Company: NewcelX Ltd.
Filing Date: 2025-07-29
Form: F-4/A
Chunk 147
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 NLS may also seek Fast Track designation from the FDA for some of its product candidates. If a therapy is intended for the treatment of a serious or life -threateningcondition and the therapy demonstrates the potential to address unmet medical needs for this condition, the therapy sponsor may apply for Fast Track designation. The FDA has broad discretion whether or not to grant this designation, so even if NLS believes a particular product candidate is eligible for this designation, there can be no assurance that the FDA would decide to grant it. Even if NLS does receive Fast Track designation, NLS may not experience a faster development process, review or approval compared to conventional FDA procedures, and receiving a Fast -Trackdesignation does not provide assurance of ultimate FDA approval. The FDA may withdraw Fast Track designation if it believes that the designation is no longer supported by data from its clinical development program. 36 NLS may also seek a priority medicines scheme, or PRIME, designation for some of its product candidates. PRIME was launched by EMA in 2016 to facilitate the development of medicines that target an unmet medical need. Through PRIME, the EMA offers early and proactive support to medicine developers with the aim of optimizing the generation of robust data on a medicine’s benefits and risks and enabling accelerated assessment of medicines applications. The overall goal is to ensure patients benefit as early as possible from therapies that may significantly improve their quality of life. PRIME focuses on improving the design of clinical trials in order to ensure the efficient generation of the necessary clinical data for inclusion in a Marketing Authorization Application, or MAA. Even if NLS obtains regulatory approval for a product candidate, its products will remain subject to ongoing regulatory oversight. Even if NLS obtains any regulatory approval for its product candidates, they will be subject to ongoing regulatory requirements for manufacturing, labeling, packaging, storage, advertising, promotion, sampling, record -keepingand submission of safety and other post -marketinformation. Any regulatory approvals that NLS 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 -marketingtesting, including Phase 4 clinical trials, and surveillance to monitor the quality, safety and efficacy of the product. The holder of an approved marketing application also must submit new or supplemental applications and obtain FDA approval for certain changes to the approved product, product labeling or manufacturing process. Advertising and promotional materials must comply with FDA rules and are subject to FDA review,