Company: NCEL
Filing Date: 2025-07-18
Form Type: F-4/A
Source: 0001213900-25-065783
Chunk: 144

Company: NewcelX Ltd.
Filing Date: 2025-07-18
Form: F-4/A
Chunk 144
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 and this may have an adverse effect on the commercial prospects for Nolazol and its ability to generate product revenues would be delayed, possibly materially. NLS cannot guarantee that NLS will receive any regulatory approvals to commercialize its product candidates in children. Changes in regulatory requirements and guidance or unanticipated events during its clinical trials may occur, which may result in necessary changes to clinical trial protocols, which could result in increased costs to us, delay its development timeline or reduce the likelihood of successful completion of its clinical trials. Changes in regulatory requirements and guidance or unanticipated events during its clinical trials may occur, as a result of which NLS may need to amend clinical trial protocols. Amendments may require it to resubmit its clinical trial protocols to IRBs for review and approval, which may impact the cost, timing or successful completion of a clinical trial. If NLS experiences delays in completion of, or if NLS terminates, any of its clinical trials, the commercial prospects for Quilience and Nolazol would be harmed and its ability to generate product revenues would be delayed, possibly materially. NLS’s development and regulatory strategy for its product candidates depends in part on published scientific literature and the FDA’s prior findings regarding the safety and efficacy of approved products containing mazindol. If the FDA does not conclude that its product candidates satisfy the requirements for the Section 505(b)(2) regulatory approval pathway, or if the requirements for its product candidates under Section 505(b)(2) are not as NLS expects, the approval pathway would likely take significantly longer, cost significantly more and entail significantly greater complications and risks than anticipated and in either case may not be successful. The Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch -WaxmanAmendments, added Section 505(b)(2) to the Federal Food, Drug, and Cosmetic Act, or FDCA, or Section 505(b)(2). Section 505(b)(2) permits the submission of an NDA where at least some of the information required for approval 35 comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference. NLS intends to seek FDA approval through the Section 505(b)(2) regulatory pathway for Quilience and may seek this regulatory pathway for other product candidates that NLS seeks to develop. If the FDA does not allow it to pursue the Section 505(b)(2) regulatory pathway as anticipated, NLS may need to conduct