Company: NCEL
Filing Date: 2025-06-09
Form Type: F-4/A
Source: 0001213900-25-052354
Chunk: 114

Company: NewcelX Ltd.
Filing Date: 2025-06-09
Form: F-4/A
Chunk 114
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 are made available to patients on a commercial scale after approval. If additional clinical experience indicates that Quilience and/or Nolazol, or other product candidates that NLS may seek to develop, have side effects or cause serious or life -threateningside effects, the development of the product candidate may fail or be delayed, or, if the product candidate has received regulatory approval, such approval may be revoked or limited. Additionally, if any of its product candidates receives marketing approval, the FDA or EMA could require it to adopt a REMS to ensure that the benefits outweigh its risks, which may include, among other things, a medication guide outlining the risks of the product for distribution to patients, a communication plan to health care practitioners, and restrictions on how or where the product can be distributed, dispensed or used. Furthermore, if NLS or others later identify undesirable side effects caused by Quilience and/or Nolazol, several potentially significant negative consequences could result, including: •regulatory authorities may suspend or withdraw approvals of such a product candidate; •regulatory authorities may require additional warnings on the label; 33 •regulatory authorities may issue negative publicity regarding the affected product, including safety communications; •NLS may be required to change the way the product is distributed, dispensed or administered, or conduct additional pre -clinicalstudies or clinical trials; •NLS may need to voluntarily recall our products; and •NLS could be sued and held liable for harm caused to patients. Any of these events could prevent it from achieving or maintaining market acceptance of the affected product candidate and could significantly harm its business, prospects, financial condition and results of operations. NLS will need to obtain FDA approval of any proposed names for its product candidates that gain marketing approval, and any failure or delay associated with such naming approval may adversely impact its business. Any name NLS intend to use for its product candidates will require approval from the FDA regardless of whether NLS has secured a formal trademark registration from the U.S. Patent and Trademark Office, or the U.S. PTO. The FDA typically conducts a review of proposed product names, including an evaluation of whether proposed names may be confused with the names of other drug products. The FDA may object to any product name NLS submit if it believes the name inappropriately implies medical claims. If the FDA objects to any of its proposed product names, NLS may be required to adopt an alternative name for its product candidates, which could result in further evaluation of proposed names