Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 22

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 22
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product candidate is eligible for this designation, there can be no assurance that the FDA would decide to grant it. Even if we do receive
Fast Track designation, we may not experience a faster development process, review or approval compared to conventional FDA procedures,
and receiving a Fast-Track designation 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 our clinical development program.

We may also seek a priority
medicines scheme, or PRIME, designation for some of our 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 we obtain regulatory approval for
a product candidate, our products will remain subject to ongoing regulatory oversight.

Even if we obtain any regulatory
approval for our product candidates, they will be subject to ongoing regulatory requirements for manufacturing, labeling, packaging, storage,
advertising, promotion, sampling, record-keeping and submission of safety and other post-market information. Any regulatory approvals
that we receive for our 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-marketing testing, 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, in addition
to other potentially applicable federal and state laws.

In addition, product manufacturers
and their facilities are subject to payment of user fees and continual review and periodic inspections by the FDA and other regulatory
authorities for compliance with current good manufacturing practices, or cGMP, requirements and adherence to commitments made in the NDA
or foreign marketing application. If a