Company: INDP
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001493152-25-010136
Chunk: 53

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1
Chunk 53
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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 effect on our business.

37

Even if we receive regulatory approval for
any product candidate, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant
additional expenses. 

Any
regulatory approvals that we may receive for our product candidates will require the submission of reports to regulatory authorities
and surveillance to monitor the safety and efficacy of the product candidate, may contain significant limitations related to use restrictions
for specified age groups, warnings, precautions or contr