Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 229

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 229
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, appropriate packaging must be selected and
tested and stability studies must be conducted to demonstrate that the drug candidate does not undergo unacceptable deterioration over
its proposed shelf-life.

The results of
product development, pre-clinical studies and clinical trials, along with descriptions of the manufacturing process, analytical tests
and other control mechanisms, proposed labeling and other relevant information are submitted to the FDA as part of an NDA requesting
approval to market the product for one or more specified indications. The submission of an NDA is subject to the payment of an application
fee, but a waiver of such fees may be obtained under specified circumstances. We will seek a waiver of these fees as a small business
submitting its first human drug application to the FDA. If the waiver is granted it would not extend to establishment or product
fees. The FDA reviews all NDAs submitted to ensure that they are sufficiently complete for substantive review before it accepts them
for filing. It may request additional information rather than accept an NDA for filing. In this event, the NDA must be resubmitted with
the additional information. The resubmitted application also is subject to review before the FDA accepts it for filing.

Once the submission
is accepted for filing, the FDA begins an in-depth review. The FDA may refuse to approve an NDA if the applicable statutory and regulatory
criteria are not satisfied or may require additional clinical or other data. Even if such data are submitted, the FDA may ultimately
decide that the NDA does not satisfy the criteria for approval. The FDA reviews an NDA to determine, among other things, whether a product
is safe and effective for its intended use and whether its manufacturing is cGMP-compliant. The FDA may refer the NDA to an advisory
committee for review and recommendation as to whether the application should be approved and under what conditions. The FDA is not bound
by the recommendation of an advisory committee, but it generally follows such recommendations. Before approving an NDA, the FDA will
typically inspect the facility or facilities where the product is manufactured and tested. The FDA will also inspect selected clinical
sites that participated in the clinical studies and may inspect the testing facilities that performed the GLP toxicology studies cited
in the NDA.

Expedited Review
and Approval

The FDA has various
specific programs, including Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval, which, in different ways, are
each intended to expedite the process for reviewing and approving drugs