Company: NCEL
Filing Date: 2025-09-03
Form Type: F-4/A
Source: 0001213900-25-084157
Chunk: 140

Company: NewcelX Ltd.
Filing Date: 2025-09-03
Form: F-4/A
Chunk 140
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 uncertain process. NLS is not permitted to market Quilience and/or Nolazol in the United States or the EU until NLS receives regulatory approval of an NDA from the FDA or MAA from the EMA, or in any foreign countries until NLS receives the requisite approval from regulatory authorities in such countries. NLS has not received regulatory clearance to conduct the additional clinical trials that are necessary to be able to submit an NDA to the FDA for Nolazol. Similarly, NLS has not received regulatory clearance in the EU to conduct clinical trials that are necessary to receive approval 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