Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 90

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 90
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 clinical trial to be repeated
or a program to be terminated, even if other studies or trials relating to the program are successful. The FDA or EMA can place a clinical
trial on hold if, among other reasons, it finds that patients enrolled in the trial are or would be exposed to an unreasonable and significant
risk of illness or injury. If safety concerns develop, Kadimastem, the FDA, the EMA or other regulatory bodies could stop its trials before
completion, which could harm its business, operating results, prospects or financial condition.

Obtaining approval of a BLA or a MAA even
after clinical trials that are believed to be successful is an uncertain process.

Kadimastem is not permitted
to market its products in the United States or the EU until it receives regulatory approval of a BLA from the FDA or MAA from the
EMA, or in any foreign countries until it receive the requisite approval from regulatory authorities in such countries.

Even if Kadimastem completes
its planned clinical trials and believe the results to be successful, all of which are uncertain, obtaining regulatory approval is an
extensive, lengthy, expensive and uncertain process, and the FDA and EMA, and other regulatory authorities may delay, limit or deny approval
of its products for many reasons, including, but not limited to:

  Kadimastem may not be able to demonstrate to their satisfaction                      
  that the product candidate is a safe or effective treatment for a given indication;  
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  the results of clinical trials may not meet the level of statistical        
  significance or clinical significance required by the regulatory agencies;  
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  disagreements regarding the number, design, size, conduct                                                                            

  a lack of acceptance of the accuracy or sufficiency of the                                                                       

  difficulties scheduling an advisory committee meeting in a                                                                                   
  timely manner or the advisory committee, or such other similar committee, may recommend against approval of Kadimastem’s application         
  or may recommend that such regulators require, as a condition of approval, additional pre-clinical studies or clinical trials, improvements  
  in the manufacturing facility and stability transportation processes and durability limitations on approved labelling, or distribution       
  and use restrictions;                                                                                                                        
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  the requirement that Kadimastem develop a