Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 232

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 232
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 FDA to be essential to the approval
of the application, for example, for new indications, dosages or strengths of an existing drug. This three-year exclusivity covers only
the conditions associated with the new clinical investigations and does not prohibit the FDA from approving ANDAs for drugs containing
the original active agent. Five-year and three-year exclusivity will not delay the submission or approval of a full NDA; however, an
applicant submitting a full NDA would be required to conduct or obtain a right of reference to all of the pre-clinical studies and adequate
and well-controlled clinical trials necessary to demonstrate safety and effectiveness.

Post-approval
Requirements

Once
an approval is granted, the FDA, European authorities and other regulatory authorities may withdraw the approval if compliance with
regulatory requirements is not maintained or if problems occur after the product reaches the market. Later discovery of previously
unknown problems with a product may result in restrictions on the product or even complete withdrawal of the product from the
market. After approval, some types of changes to the approved product, such as adding new indications, manufacturing changes and
additional labeling claims, are subject to further regulatory authority review and approval. Some of these modifications, especially
adding indications, would likelyrequire additional clinical studies. In addition, the FDA may require testing and
surveillance programs to monitor the effect of approved products that have been commercialized, and the FDA has the power to prevent
or limit further marketing of a product based on the results of these post-marketing programs.

Any drug product
manufactured or distributed by us pursuant to FDA approvals are subject to continuing regulation by the FDA, including, among other things
record-keeping requirements; cGMPs; reporting of adverse experiences with the drug; providing the FDA with updated safety and efficacy
information; drug sampling and distribution requirements; notifying the FDA and gaining its approval of specified manufacturing or labeling
changes; and complying with FDA promotion and advertising requirements.

Drug manufacturers
and other entities involved in the manufacture and distribution of approved drugs are required to register their establishments with
the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and some state agencies for compliance
with cGMP and other laws.

Pursuant to the
Affordable Care Act (discussed in greater detail below), the Centers for Medicare & Medicaid Services (CMS) is required to collect
and publish information reported by applicable manufacturers about payments and other transfers of value manufacturers have made to physicians
and teaching hospitals.