Company: INDP
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001493152-25-010136
Chunk: 1345

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1A
Chunk 1345
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MA or comparable foreign regulatory authorities, that
such product candidates are safe and effective for their intended uses, and in the case of biological products, that such product candidates
are safe, pure and potent. Results from nonclinical studies and clinical trials can be interpreted in different ways. Even if we believe
available nonclinical or clinical data support the safety purity, potency or efficacy of our product candidates, such data may not be
sufficient to obtain approval from the FDA and comparable foreign regulatory authorities. The FDA, EMA or comparable foreign regulatory
authorities, as the case may be, may also require us to conduct additional preclinical studies or clinical trials for our product candidates
either prior to or post-approval, or may object to elements of our clinical development program.

The
FDA, EMA or comparable foreign regulatory authorities can delay, limit or deny approval of a product candidate for many reasons, including:

    ●
    such
    authorities may disagree with the design or execution of our clinical trials;

    ●
    negative
    or ambiguous results from our clinical trials or results may not meet the level of statistical significance required by the FDA,
    EMA or comparable foreign regulatory agencies for approval;

    ●
    serious
    and unexpected drug-related side effects may be experienced by participants in our clinical trials or by individuals using drugs
    similar to our product candidates;

    ●
    the
    population studied in the clinical trial may not be sufficiently broad or representative to assure safety in the full population
    for which we seek approval;

    ●
    such
    authorities may not accept clinical data from trials that are conducted at clinical facilities or in countries where the standard
    of care is potentially different from that of their own country;

    ●
    we
    may be unable to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks;

    ●
    such
    authorities may disagree with our interpretation of data from preclinical studies or clinical trials;

    ●
    such
    authorities may not agree that the data collected from clinical trials of our product candidates are acceptable or sufficient to
    support the submission of a BLA, NDA or other submission or to obtain regulatory approval in the U.S. or elsewhere, and such authorities
    may impose requirements for additional preclinical studies or clinical trials;

    ●
    such
    authorities may disagree with us regarding the formulation, labeling and/or the product specifications of our product candidates;

    ●
    approval
    may be