Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 15

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 15
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 is a safe or effective treatment for a given indication;      
  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 or implementation of our clinical trials, or with our interpretation of data from pre-clinical studies or clinical trials;                  
  a lack of acceptance of the accuracy or sufficiency of the data generated at our clinical trial sites to demonstrate, among others, that clinical and other benefits outweigh its safety risks or...  
  difficulties scheduling an advisory committee meeting in a timely manner or the advisory committee, or such other similar committee, may recommend against approval of our application or may rec...  

  the requirement that we develop a Risk Evaluation and Mitigation Strategy, or REMS, as a condition of approval, which may or may not be feasible for us;  
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  the identification of deficiencies in the manufacturing processes or facilities of third-party manufacturers with which we enter into agreements for clinical and commercial supplies;                
  changes in approval policies or the adoption of new regulations by such regulators; and                                                                                                               
  we may be unable to be granted a PIP deferral which we intend to request from the EMA for delayed clinical trials and subsequent approval in children; this may delay our clinical trial program ...  

Before we can submit an NDA
to the FDA, we must conduct pivotal trials, in addition to human pharmacokinetic and bioavailability studies, that will be substantially
broader than our Phase 2 trial for Nolazol and or Quilience. An NDA must be supported by extensive clinical and pre-clinical data, as
well as extensive information regarding chemistry, manufacturing and controls to demonstrate the safety and effectiveness of the applicable
product candidate. The number and types of pre-clinical studies and clinical trials that will be required varies depending on the product
candidate, the disease or condition that the product candidate is designed to target and the regulations applicable to any particular
product candidate. Obtaining approval of an NDA is a lengthy, expensive and uncertain process, and we may not be successful in obtaining
approval. The FDA review processes can take years to complete and approval is never guaranteed.

In this respect, we will also
need to agree on a protocol with