Company: INDP
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001493152-25-010136
Chunk: 55

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1
Chunk 55
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 in response and could generate negative publicity.

The
FDA’s and other regulatory authorities’ policies may change and additional government regulations may be promulgated that
could prevent, limit or delay marketing authorization of any product candidates we develop. We also cannot predict the likelihood, nature
or extent of government regulation that may arise from future legislation or administrative action, either in the United States or abroad.
If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not
able to maintain regulatory compliance, we may be subject to enforcement action and we may not achieve or sustain profitability.

The
FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.

The
FDA strictly regulates marketing, labeling, advertising and promotion of prescription drugs. These regulations include standards and
restrictions for direct-to-consumer advertising, industry-sponsored scientific and educational activities, promotional activities involving
the internet and off-label promotion. Any regulatory approval that the FDA grants is limited to those specific diseases and indications
for which a product is deemed to be safe and effective by FDA. While physicians in the United States may choose, and are generally permitted,
to prescribe drugs for uses that are not described in the product’s labeling and for uses that differ from those tested in clinical
trials and approved by the regulatory authorities, our ability to promote any products will be narrowly limited to those indications
that are specifically approved by the FDA.

38

If
we are found to have promoted such off-label uses, we may become subject to significant liability. The U.S. federal government has levied
large civil and criminal fines against companies for alleged improper promotion of off-label use and has enjoined several companies from
engaging in off-label promotion. The FDA has also requested that companies enter into consent decrees or permanent injunctions under
which specified promotional conduct is changed or curtailed. If we cannot successfully manage the promotion of any product candidates,
if approved, we could become subject to significant liability, which would materially adversely affect our business and financial condition.

Risks
Related to Our Dependence on Third Parties

The
commercial success of our product candidates depends upon their market acceptance among physicians, patients, healthcare payors and the
medical community.

Even
if our product candidates obtain regulatory approval, our products, if any, may not gain market acceptance among physicians, patients,
healthcare payors and the medical community. The degree of market acceptance of any of our approved product candidates will depend