Company: INDP
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001493152-25-010136
Chunk: 20

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1
Chunk 20
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. A CRL indicates that the review cycle
of the application is complete, and the application will not be approved in its present form. A CRL usually describes the specific deficiencies
in the NDA or BLA identified by the FDA and may require additional clinical data, including additional clinical trials, or other significant
and time-consuming requirements related to clinical trials, nonclinical studies or manufacturing. If a CRL is issued, the sponsor must
resubmit the NDA or BLA, addressing all of the deficiencies identified in the letter, or withdraw the application. Even if such data
and information are submitted, the FDA may decide that the NDA or BLA does not satisfy the criteria for approval.

If
regulatory approval of a product is granted, such approval will be granted for particular indications and may entail limitations on the
indicated uses for which such product may be marketed. For example, the FDA may approve the NDA or BLA with a Risk Evaluation and Mitigation
Strategy, or REMS, to ensure the benefits of the product outweigh its risks. A REMS is a safety strategy to manage a known or potential
serious risk associated with a product and to enable patients to have continued access to such medicines by managing their safe use,
and could include medication guides, physician communication plans, or elements to assure safe use, such as restricted distribution methods,
patient registries and other risk minimization tools. The FDA also may condition approval on, among other things, changes to proposed
labeling or the development of adequate controls and specifications. The FDA may also require one or more Phase 4 post-market studies
and surveillance to further assess and monitor the product’s safety and effectiveness after commercialization, and may limit further
marketing of the product based on the results of these post-marketing studies.

Expedited
Development and Review Programs

The
FDA offers a number of expedited development and review programs for qualifying product candidates. For example, the fast track program
is intended to expedite or facilitate the process for reviewing new products that meet certain criteria. Specifically, product candidates
are eligible for fast track designation if they are intended to treat a serious or life-threatening disease or condition and demonstrate
the potential to address unmet medical needs for the disease or condition. Fast track designation applies to the combination of the product
candidate and the specific indication for which it is being studied. The sponsor of a fast track product candidate has opportunities
for more frequent interactions with the review team during product development and, once an