Company: NCEL
Filing Date: 2025-06-09
Form Type: F-4/A
Source: 0001213900-25-052354
Chunk: 117

Company: NewcelX Ltd.
Filing Date: 2025-06-09
Form: F-4/A
Chunk 117
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 for approval. Even if NLS obtains such designations for one or more of its product candidates, there can be no assurance that NLS will realize their intended benefits. For example, NLS may seek a Breakthrough Therapy designation from the FDA for one or more of its product candidates. A Breakthrough Therapy designation is defined as a therapy that is intended, alone or in combination with one or more other therapies, to treat a serious or life -threateningdisease or condition, if preliminary clinical evidence indicates that the therapy may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. For therapies that have Breakthrough Therapy designation, interaction and communication between the FDA and the sponsor of the trial can help to identify the most efficient path for clinical development while minimizing the number of patients placed in ineffective control regimens. Therapies with Breakthrough Therapy designation from the FDA are also eligible for accelerated approval. Designation as a Breakthrough Therapy is within the discretion of the FDA. Accordingly, even if NLS believes one of its product candidates meets the criteria for Breakthrough Therapy designation, the FDA may disagree and instead determine not to make such designation. In any event, the receipt of a Breakthrough Therapy designation for a product candidate may not result in a faster development process, review or approval compared to therapies considered for approval under conventional FDA procedures and does not assure ultimate approval by the FDA. In addition, even if one or more of its product candidates qualify for Breakthrough Therapy designation, the FDA may later decide that such product candidates no longer meet the conditions for qualification. 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. 35 NLS may also seek a priority medicines scheme