Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 17

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 17
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 and the EU. Although the FDA may accept data from clinical trials conducted outside the United States, acceptance of
this data is subject to certain conditions imposed by the FDA. For example, the clinical trial must be well-designed and conducted
and performed by qualified investigators in accordance with ethical principles such as IRB or ethics committee approval and informed
consent. The study population must also adequately represent the U. S. population, and the data must be applicable to the U. S.
population and U. S. medical practice in ways that the FDA deems clinically meaningful. Generally, the subject population for any
clinical trials conducted outside of the United States must be representative of the U. S. population. In addition, while these
clinical trials are subject to the applicable local laws, FDA acceptance of the data will be dependent upon its determination that
the trials were conducted consistent with all applicable U. S. laws and regulations. There can be no assurance the FDA or
international regulatory authorities will accept data from trials conducted outside of the United States or inside the United
States, as the case may be, as adequate support of a marketing application. If the FDA or international regulatory authorities do
not accept the data from sites in our globally conducted clinical trials, it would likely result in the need for additional trials,
which would be costly and time-consuming and could delay or permanently halt the development of one or more of our product
candidates.

Our product candidates may cause undesirable
side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial potential or result
in significant negative consequences following regulatory approval, if obtained.

During the conduct of clinical
trials, patients may experience changes in their health, including illnesses, injuries, discomforts or a fatal outcome. It is possible
that as we develop Quilience and Nolazol, or other product candidates that we may seek to develop, in larger, longer and more extensive
clinical trials as use of our product candidates becomes more widespread if they receive regulatory approval, illnesses, injuries, discomforts
and other adverse events that were observed in earlier clinical trials, as well as conditions that did not occur or went undetected in
previous clinical trials, will be reported by subjects. Many times, side effects are only detectable after investigational products are
tested in larger scale, Phase 2b/Phase 3 clinical trials or, in some cases, after they are made available to patients on a commercial
scale after approval. If additional clinical experience indicates that