Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 228

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 228
---
 dosage tolerance and optimal dosage.                         
 ───────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────

  Phase 3. Clinical                                                                                                                             

  Phase 4. The                                                                                                                            
  FDA may require that the sponsor conduct additional clinical trials following new drug approval. The purpose of these trials, known as  
  Phase 4 studies, is to monitor long-term risks and benefits, study different dosage levels or evaluate safety and effectiveness.        
  In recent years, the FDA has increased its reliance on these trials. Phase 4 studies usually involve thousands of participants.         
  Phase 4 studies also may be initiated by the company sponsoring the new drug to gain broader market value for an approved drug.         
 ──────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────

Human clinical
trials are inherently uncertain and Phase 1, Phase 2, Phase 3 and Phase 4 testing may not be successfully completed.
The FDA or the sponsor may suspend a clinical trial at any time for a variety of reasons, including a finding that the research subjects
or patients are being exposed to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval of a clinical trial
at its institution if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the drug has been
associated with unexpected serious harm to patients.

During the development
of a new drug, sponsors are given opportunities to meet with the FDA at certain points. These points are typically prior to the submission
of an IND, at the end of Phase 2 and before an NDA is submitted. Meetings at other times may also be requested. These meetings can
provide an opportunity for the sponsor to share information about the data gathered to date and for the FDA to provide advice on the
next phase of development. Sponsors typically use the meeting at the end of Phase 2 to discuss their Phase 2 clinical results
and present their plans for the pivotal Phase 3 clinical trial that they believe will support the approval of the NDA.

Concurrent with
clinical trials, sponsors usually complete any remaining animal safety studies and also develop additional information about the chemistry
and physical characteristics of the drug and finalize a process for manufacturing commercial quantities of the product in accordance
with cGMP requirements. The manufacturing process must be capable of consistently producing quality batches of the drug and the manufacturer
must develop methods for testing the quality, purity and potency of the drug. Additionally