Company: INDP
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001493152-25-010136
Chunk: 52

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1
Chunk 52
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 to foreign markets, approval procedures vary among countries and, in addition to the foregoing risks, may involve additional
product testing, administrative review periods and agreements with pricing authorities. Even if we eventually complete clinical trials
and receive approval of a BLA, NDA or comparable foreign marketing application for our product candidates, the FDA or comparable foreign
regulatory authority may grant approval contingent on the performance of costly additional clinical trials and/or the implementation
of a REMS, which may be required because the FDA believes it is necessary to ensure safe use of the product after approval. Any delay
in obtaining, or inability to obtain, applicable regulatory approval would delay or prevent commercialization of that product candidate
and would materially adversely impact our business and prospects.

Even
if we obtain FDA approval for any of our product candidates in the United States, we may never obtain approval for or commercialize such
candidates in any other jurisdiction, which would limit our ability to realize their full market potential.

In
order to market any products in any particular jurisdiction, we must establish and comply with numerous and varying regulatory requirements
on a country-by-country basis regarding safety and efficacy. Approval by the FDA in the United States does not ensure approval by regulatory
authorities in other countries or jurisdictions. However, the failure to obtain approval in one jurisdiction may negatively impact our
ability to obtain approval elsewhere. In addition, clinical trials conducted in one country may not be accepted by regulatory authorities
in other countries, and regulatory approval in one country does not guarantee regulatory approval in any other country.

Approval
processes vary among countries and can involve additional product testing and validation, as well as additional administrative review
periods. Seeking foreign regulatory approval could result in difficulties and increased costs for us and require additional preclinical
studies or clinical trials which could be costly and time consuming. Regulatory requirements can vary widely from country to country
and could delay or prevent the introduction of our products in those countries. We do not have any product candidates approved for sale
in any jurisdiction, including in international markets, and we do not have experience in obtaining regulatory approval in international
markets. If we fail to comply with regulatory requirements in international markets or to obtain and maintain required approvals, or
if regulatory approvals in international markets are delayed, our target market will be reduced and our ability to realize the full market
potential of any product we develop will be unrealized.

Disruptions
at the FDA and other government agencies caused by funding shortages or global health concerns could hinder their ability to hire, retain