Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 226

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 226
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 an applicant to administrative
or judicial sanctions, any of which could have a material adverse effect on Kadimastem. These sanctions could include refusal to approve
pending applications, withdrawal of an approval, imposition of a clinical hold, issuance of warning letters, product seizures, total
or partial suspension of production or distribution, injunctions, fines, disgorgement, and civil or criminal penalties.

The process required
by the FDA before a drug may be marketed in the United States generally involves the following:

  completion of pre-clinical laboratory                                                                        

  submission to the FDA of an                                                           
  IND application, which must become effective before human clinical trials may begin;  
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  performance of adequate and                                                                                                               
  well-controlled human clinical trials according to GCPs, to establish the safety and efficacy of the proposed drug for its intended use;  
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  submission to the FDA of an  

  satisfactory completion of an                                                                                                          

  satisfactory completion of FDA                                 

  FDA review and approval of the  

The
testing and approval process requires substantial time, effort and financial resources, and we cannot be certain that any approvals for
a product candidate will be granted on a timely basis, if at all.

Once a product
candidate is identified for development, it enters the pre-clinical testing stage. Pre-clinical tests include laboratory evaluations
of product chemistry, toxicity and formulation, as well as animal studies. An IND sponsor must submit the results of the pre-clinical
tests, together with manufacturing information and analytical data, to the FDA as part of the IND. Some pre-clinical testing may
continue after the IND is submitted. In addition to including the results of the pre-clinical studies, the IND will also include a clinical
trial protocol detailing, among other things, the objectives of the clinical trial, the parameters to be used in monitoring safety and,
depending on the phase of the study, the effectiveness criteria to be evaluated. The IND automatically becomes effective 30 days
after receipt by the FDA, unless the FDA, within the 30-day time period, places the IND on clinical hold. In such a case, the IND sponsor
and the FDA must resolve any outstanding concerns before clinical trials can begin. A clinical hold may occur at any time during the
life of an IND, due to safety concerns or