Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 227

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 227
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 non-compliance, and may affect one or more specific studies or all studies conducted under
the IND.

All clinical trials
must be conducted under the supervision of one or more qualified investigators in accordance with the FDA’s GCP regulations. These
regulations include the requirement that all research subjects provide informed consent. Further, an IRB must review and approve the
plan for any clinical trial, including the informed consent document, before it commences at any institution. An IRB considers, among
other things, whether the risks to individuals participating in the trials are minimized and are reasonable in relation to anticipated
benefits. The IRB also approves the investigator brochure and other information about the trial distributed by the sponsor and the consent
form that must be provided to each trial subject or his or her legal representative and must monitor the study until completed. All clinical
trials must be conducted under protocols detailing the objectives of the trial, dosing procedures, research subject inclusion and exclusion
criteria and the safety and effectiveness criteria to be evaluated. Each protocol must be submitted to the FDA as part of the IND, and
progress reports detailing the status of the clinical trials must be submitted to the FDA annually. Sponsors must also report within
set timeframes to FDA serious and unexpected adverse reactions, any clinically important increase in the rate of a serious suspected
adverse reaction over that listed in the protocol or investigation brochure, or any findings from other studies or animal or in-vitro
testing that suggest a significant risk in humans exposed to the drug. Sponsors must also report to FDA certain amendments to the protocol
and other essential information concerning the IND that does not fall within the scope of other required reports.

Human clinical
trials are typically conducted in three sequential phases that may overlap or be combined:

  Phase 1. The                                                                                                                            
  drug is initially introduced into healthy human subjects and tested for safety, dosage tolerance, absorption, metabolism, distribution  
  and elimination. In the case of some products for severe or life-threatening diseases, such as cancer, especially when the product may  
  be inherently too toxic to ethically administer to healthy volunteers, the initial human testing is often conducted in patients.        
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  Phase 2. Clinical                                                                                                                        
  trials are performed on a limited patient population intended to identify possible adverse effects and risks, to preliminarily evaluate  
  the efficacy of the product for specific targeted diseases and to determine