Company: INDP
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001493152-25-010136
Chunk: 1347

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1A
Chunk 1347
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 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
or deploy key leadership and other personnel, prevent new or modified products from being developed, reviewed, approved or commercialized
in a timely manner or at all, which could negatively impact our business.

The
ability of the FDA and foreign regulatory authorities to review and approve new products can be affected by a variety of factors, including
government budget and funding levels, statutory, regulatory, and policy changes, the FDA’s or foreign regulatory authorities’
ability to hire and retain key personnel and accept the payment of user fees, and other events that may otherwise affect the FDA’s
or foreign regulatory authorities’ ability to perform routine functions. Average review times at the FDA and foreign regulatory
authorities have fluctuated in recent years as a result. In addition, government funding of other government agencies that fund research
and development activities is subject to the political process, which is inherently fluid and unpredictable.

Disruptions
at the FDA and other agencies, such as the EMA following its relocation to Amsterdam and resulting staff changes, may also slow the time
necessary for new drugs, and biologics or modifications to approved drugs and biologics to be reviewed and/or approved by necessary government
agencies, which would adversely affect our business. For example, over the last several years, the U.S. government has shut down several
times and certain regulatory agencies, such as the FDA, have had to furlough critical FDA employees and stop critical activities.

Separately,
in response to the global COVID-19 pandemic, the FDA postponed most inspections of domestic and foreign manufacturing facilities at various
points. Even though the FDA has since resumed standard inspection operations, any resurgence of the virus or emergence of new variants
may lead to further inspectional or administrative delays. If a prolonged government shutdown occurs, or if global health concerns continue
to prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews, or other regulatory activities,
it could significantly impact the ability of the FDA or other regulatory authorities to timely review and process our regulatory submissions,
which could have a material adverse