Company: NCEL
Filing Date: 2025-09-10
Form Type: 424B3
Source: 0001213900-25-086600
Chunk: 133

Company: NewcelX Ltd.
Filing Date: 2025-09-10
Form: 424B3
Chunk 133
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 of an MAA for Quilience in Europe. As such, NLS has not submitted an MAA for any of its product candidates. NLS may be able make its products available on a named patient basis and generate pre -approvalrevenues from compassionate use activities leveraging on an expanded access policy in certain countries around the world. 32 Even if NLS completes its planned clinical trials and believes the results to be successful, all of which are uncertain, obtaining regulatory approval is an extensive, lengthy, expensive and uncertain process, and the FDA and EMA, and other regulatory authorities may delay, limit or deny approval of Quilience and/or Nolazol for many reasons, including, but not limited to: •NLS may not be able to demonstrate to their satisfaction that the product candidate is a safe or effective treatment for a given indication; •the results of clinical trials may not meet the level of statistical significance or clinical significance required by the regulatory agencies; •disagreements regarding the number, design, size, conduct or implementation of NLS’s clinical trials, or with our interpretation of data from pre -clinicalstudies or clinical trials; •a lack of acceptance of the accuracy or sufficiency of the data generated at our clinical trial sites to demonstrate, among others, that clinical and other benefits outweigh its safety risks or to support the submission of an NDA or MAA; •difficulties scheduling an advisory committee meeting in a timely manner or the advisory committee, or such other similar committee, may recommend against approval of our application or may recommend that such regulators require, as a condition of approval, additional pre -clinicalstudies or clinical trials, limitations on approved labeling, or distribution and use restrictions; •the requirement that NLS develop a Risk Evaluation and Mitigation Strategy, or REMS, as a condition of approval, which may or may not be feasible for us; •the identification of deficiencies in the manufacturing processes or facilities of third -partymanufacturers with which we enter into agreements for clinical and commercial supplies; •changes in approval policies or the adoption of new regulations by such regulators; and •NLS may be unable to be granted a PIP deferral which we intend to request from the EMA for delayed clinical trials and subsequent approval in children; this may delay its clinical trial program or approvals for adults, or we may have successful clinical trial results for adults but not children (if NLS were required to conduct pediatric studies prior to the receipt of an NDA or MAA for use of its product candidates