Company: NCEL
Filing Date: 2025-07-18
Form Type: F-4/A
Source: 0001213900-25-065783
Chunk: 143

Company: NewcelX Ltd.
Filing Date: 2025-07-18
Form: F-4/A
Chunk 143
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 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; 34 •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 intends 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 submits 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 with the potential for additional delays and costs. Obtaining regulatory approval for clinical trials of Nolazol in children will be more difficult than obtaining such approvals for adult clinical trials since the requirements for regulatory approval to conduct pediatric clinical trials are more stringent. Pediatric drug development requires additional nonclinical work (such as animal studies in juvenile animals and additional reproductive toxicity work), as well as staged clinical work in determining safe dosing and monitoring. These additional tasks involve investment of significant additional resources beyond those needed for approval of the drug for adults. Approval of Nolazol for use in children may be significantly delayed due to these additional requirements