Company: NCEL
Filing Date: 2025-06-09
Form Type: F-4/A
Source: 0001213900-25-052354
Chunk: 116

Company: NewcelX Ltd.
Filing Date: 2025-06-09
Form: F-4/A
Chunk 116
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, 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 comes from studies 34 not conducted by or for the applicant and for which the applicant has not obtained a right of reference. NLS intend 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 additional pre -clinicaland or clinical trials, provide additional data and information and meet additional standards for regulatory approval. If this were to occur, the time and financial resources required to obtain FDA approval, and complications and risks associated with FDA approval, would substantially increase. NLS may need to obtain additional funding, which could result in significant dilution to the ownership interests of its then existing shareholders to the extent NLS issue equity securities or convertible debt. NLS cannot assure you that NLS would be able to obtain such additional financing on terms acceptable to us, if at all. Moreover, inability to pursue the Section 505(b)(2) regulatory pathway could result in new competitive product candidates reaching the market faster than its product candidates, which could materially adversely impact its competitive position and prospects. Even if NLS is allowed to pursue the Section 505(b)(2) regulatory pathway, NLS cannot assure you that its product candidates will receive the requisite approvals for commercialization. NLS may seek designations for its product candidates with the FDA and other comparable regulatory authorities that are intended to confer benefits such as a faster development process or an accelerated regulatory pathway, but there can be no assurance that NLS will successfully obtain such designations. In addition, even if one or more of its product candidates are granted such designations, NLS may not be able to realize the intended benefits of such designations. The FDA, and other comparable regulatory authorities, offer certain designations for product candidates that are intended to encourage the research and development of pharmaceutical products addressing conditions with significant unmet medical need. These designations may confer benefits such as additional interaction with regulatory authorities, a potentially accelerated regulatory pathway and priority review. There can be no assurance that NLS will successfully obtain such designation for Quilience and/or Nolazol. In addition, while such designations could expedite the development or approval process, they generally do not change the standards