Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 230

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 230
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. Even if a drug qualifies for one or more of these programs,
the FDA may later decide that the drug no longer meets the conditions for qualification or that the time period for FDA review or approval
will be shortened. Generally, drugs that are eligible for these programs are those for serious or life-threatening conditions, those
with the potential to address unmet medical needs and those that offer meaningful benefits over existing treatments. For example, Fast
Track is a process designed to facilitate the development and expedite the review of drugs to treat serious or life-threatening diseases
or conditions and fill unmet medical needs, and Breakthrough Therapy designation is designed to expedite the development and review of
drugs that are intended to treat a serious condition where preliminary clinical evidence indicates that the drug may demonstrate substantial
improvement over available therapy on a clinically significant endpoint(s). Priority review is designed to give drugs that offer major
advances in treatment or provide a treatment where no adequate therapy exists an initial review within six months as compared to
a standard review time of ten months. Although Fast Track, Breakthrough Therapy designation and priority review do not affect the
standards for approval, the FDA will attempt to facilitate early and frequent meetings with a sponsor of a Fast Track or Breakthrough
Therapy designated drug and expedite review of the application for a drug designated for priority review. The FDA will also provide Breakthrough
Therapy designated drugs intensive guidance on an efficient drug development program and provide these drug developers with an organizational
commitment from the FDA involving senior managers. Since sponsors can design clinical trials in a number of ways, in providing its guidance
for drugs designated as breakthrough therapies, the FDA will seek to ensure that the sponsor of the product designated as a breakthrough
therapy receives timely advice and interactive communications in order to help the sponsor design and conduct a development program as
efficiently as possible. During these interactions, the FDA may suggest, or a sponsor can propose, alternative clinical trial designs
(e. g., adaptive designs, an enrichment strategy, use of historical controls) that may result in smaller trials or more efficient trials
that require less time to complete. Such trial designs could also help minimize the number of patients exposed to a potentially less
efficacious treatment (i. e., the control group treated with available therapy).

Accelerated Approval,
which is described in 21 C. F. R. § 314.500 et seq

Patent Term
Restoration and Marketing Exclusivity

Depending upon
the timing,