Company: NCEL
Filing Date: 2025-06-23
Form Type: F-4/A
Source: 0001213900-25-056787
Chunk: 99

Company: NewcelX Ltd.
Filing Date: 2025-06-23
Form: F-4/A
Chunk 99
---
 would be delayed and NLS may require additional capital as a result thereof. In addition, NLS may request a Paediatric Investigation Plan, or PIP, deferral in order to delay conducting clinical trials for Quilience in children until after NLS receives an MAA from the EMA for the use of Quilience in adults. A PIP deferral, as can be agreed upon by the EMA, allows an applicant to delay studies in children until after there is sufficient data on use in adults; NLS anticipates that NLS will be able to receive a PIP deferral from the EMA for Quilience; however, there is no guarantee that this deferral will be granted, which could impact its planned development process and would make the product candidate approval process more costly. The commencement and completion of clinical trials can be delayed or prevented for a number of reasons. NLS may not be able to commence or complete the clinical trials that would support its submission of an NDA to the FDA or MAA to the EMA. Drug development is a long, expensive and uncertain process, and delay or failure can occur at any stage of any of its clinical trials. Clinical trials can be delayed or prevented for a number of reasons, including: •difficulties obtaining regulatory approval to commence a clinical trial or complying with conditions imposed by a regulatory authority regarding the scope or term of a clinical trial; 24 •delays in reaching or failing to reach agreement on acceptable terms with prospective contract research organizations, or CROs, and trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; •insufficient or inadequate supply or quality of a product candidate or other materials necessary to conduct our clinical trials; •if the FDA or EMA elect to enact policy changes, as a result of a pandemic threat or otherwise; •difficulties obtaining institutional review board, or IRB, approval to conduct a clinical trial at a prospective site; and •challenges recruiting and enrolling patients to participate in clinical trials for a variety of reasons, including size and nature of patient population, proximity of patients to clinical sites, eligibility criteria for the trial, nature of trial protocol, availability of approved effective treatments for the relevant disease, and competition from other clinical trial programs for similar indications. Clinical trials may also be delayed or terminated as a result of ambiguous or negative interim results. In addition, a clinical trial may be suspended or terminated by us, the FDA, the