Company: NCEL
Filing Date: 2025-06-09
Form Type: F-4/A
Source: 0001213900-25-052354
Chunk: 111

Company: NewcelX Ltd.
Filing Date: 2025-06-09
Form: F-4/A
Chunk 111
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 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 in adults), or vice versa. Before NLS can submit an NDA to the FDA, NLS must conduct pivotal trials, in addition to human pharmacokinetic and bioavailability studies, that will be substantially broader than its Phase 2 trial for Nolazol and or Quilience. An NDA must be supported by extensive clinical and pre -clinicaldata, as well as extensive information regarding chemistry, manufacturing and controls to demonstrate the safety and effectiveness of the applicable product candidate. The number and types of pre -clinicalstudies and clinical trials that will be required varies depending on the product candidate, the disease or condition that the product candidate is designed to target and the regulations applicable to any particular product candidate. Obtaining approval of an NDA is a lengthy, expensive and uncertain process, and NLS may not