Company: NCEL
Filing Date: 2025-02-10
Form Type: F-3
Source: 0001213900-25-011823
Chunk: 84

Company: NewcelX Ltd.
Filing Date: 2025-02-10
Form: F-3
Chunk 84
---
 and where it plans to seek itself or with collaborators regulatory approval to commercialize its product
candidates in North America, the EU and in additional foreign countries. Clinical trials conducted in one country may not be accepted
by regulatory authorities in other countries and regulatory approval in one country does not ensure approval in any other country, while
a failure or delay in obtaining regulatory approval in one country may have a negative effect on the regulatory approval process in others.
For example, approval in the U.S. by the FDA does not ensure approval by regulatory authorities in other countries or jurisdictions, and
approval by one foreign regulatory authority does not ensure approval by the FDA, EMA, or regulatory authorities in other countries. Approval
procedures vary among jurisdictions and can be lengthy and expensive, and involve requirements and administrative review periods different
from, and potentially greater than, those in the U.S., including additional pre-clinical studies or clinical trials. Even if Kadimastem’s
product candidates are approved, regulatory approval for any product may be withdrawn by the regulatory authorities in a particular jurisdiction.

Even if a product is approved,
the FDA, EMA or another applicable regulatory authority, as the case may be, may limit the indications for which the product may be marketed,
require extensive warnings on the product labeling or require expensive and time-consuming post-approval commitments including clinical
trials or onerous risk management activities, including REMS, in the U.S. as conditions of approval to help ensure that the
benefits of the drug outweigh the potential risks. REMS can include medication guides, communication plans for health care professionals,
and elements to assure safe use, or ETASU. ETASU can include, but are not limited to, special training or certification for prescribing
or dispensing, dispensing only under certain circumstances, special monitoring, and the use of patient registries. The requirement for
a REMS can materially affect the potential market and profitability of the drug. Moreover, product approval may require substantial post-approval
testing and surveillance to monitor the drug’s safety or efficacy. Once granted, product approvals may be withdrawn if compliance
with regulatory standards is not maintained or problems are identified following initial marketing. In many countries outside the U.S.,
a product candidate must be approved for reimbursement before it can be approved for sale in that country. In some cases, the price that
Kadimastem intend to charge for a product is also subject to approval.

Regulatory authorities in
countries outside of the U.S. and the