Company: NCEL
Filing Date: 2025-03-31
Form Type: F-4/A
Source: 0001213900-25-026428
Chunk: 613

Company: NewcelX Ltd.
Filing Date: 2025-03-31
Form: F-4/A
Chunk 613
---
 entailed in conducting each such trial, including dosages, and the order of such trials with each of our product candidates or whether such trials will be conducted at all; •improved convenience relating to the prescription of and use of Nolazol for prescribers and patients (and their parents); •our expectations regarding the supply of mazindol; •third -partypayor reimbursement for Quilience, Nolazol, and or any of our pipeline drugs; •our estimates regarding anticipated expenses, capital requirements and our needs for additional financing; •changes to the narcolepsy patient market size and market adoption of Quilience by physicians and patients; Annex F-iv •the timing, cost, regulatory approvals or other aspects of the commercial launch of Quilience and Nolazol; •submission of a Marketing Authorisation Application, or MAA, and New Drug Application, or NDA, with the EMA and FDA for Quilience, Nolazol, and or any of our pipeline drugs, respectively; •completion and receiving favorable results of clinical trials for Quilience, Nolazol, and or any of our pipeline drugs; •issuance of patents to us by the U.S. Patent and Trademark Office, or PTO, and other governmental patent agencies; •new issuances of orphan drug designations; •the overall global political and economic environment in the countries in which we operate; •the development and approval of the use of mazindol for additional indications other than narcolepsy and attention deficit hyperactivity disorder, or ADHD; •the development and commercialization, if any, of any other product candidates that we may seek to develop; •the use of mazindol controlled release, or CR, for treatment of additional indications other than narcolepsy, idiopathic hypersomnia, or IH, and ADHD; and •the ability of our management team to lead the development of our product candidates, conclude a strategic partnership deal for Mazindol or any of our pipeline compounds. These statements are only current predictions and are subject to known and unknown risks, uncertainties and other factors that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from those anticipated by the forward -lookingstatements. We discuss many of these risks in this in greater detail under Item 3.D. “Risk Factors” and elsewhere in this annual report. You should not rely upon forward -lookingstatements as predictions of future events.