Company: INDP
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001493152-25-010136
Chunk: 17

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1
Chunk 17
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unexpected serious harm to patients. In addition, some clinical trials are overseen by an independent group of qualified experts organized
by the sponsor, known as a data safety monitoring board or committee. Depending on its charter, this group may determine whether a trial
may move forward at designated check points based on access to certain data from the trial. There are also requirements governing the
reporting of ongoing clinical studies and clinical study results to public registries, including clinicaltrials.gov.

The
clinical investigation of a drug is generally divided into three phases. Although the phases are usually conducted sequentially, they
may overlap or be combined.

    ●
    Phase 1. The product candidate
    is initially introduced into healthy human subjects or patients with the target disease or condition. These studies are designed
    to test the safety, dosage tolerance, absorption, metabolism and distribution of the investigational product in humans, the side
    effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness.

16

    ●
    Phase 2. The product candidate
    is administered to a limited patient population with a specified disease or condition to evaluate the preliminary efficacy, optimal
    dosages and dosing schedule and to identify possible adverse side effects and safety risks. Multiple Phase 2 clinical trials may
    be conducted to obtain information prior to beginning larger and more expensive Phase 3 clinical trials.

    ●
    Phase 3. The product candidate
    is administered to an expanded patient population to further evaluate dosage, to provide statistically significant evidence of clinical
    efficacy and to further test for safety, generally at multiple geographically dispersed clinical trial sites. These clinical trials
    are intended to establish the overall risk/benefit ratio of the investigational product and to provide an adequate basis for product
    approval.

Post-approval
trials, sometimes referred to as Phase 4 studies, may be conducted after initial marketing approval. These trials are used to gain additional
experience from the treatment of patients in the intended therapeutic indication. In certain instances, the FDA may mandate the performance
of Phase 4 clinical trials as a condition of approval of an NDA.

During
the development of a product candidate, sponsors are given opportunities to meet with the FDA at certain points. These points may be
prior to submission of an IND, at the end of Phase 2, and before an NDA or BLA is submitted. Meetings at other times may be requested.
These meetings can provide an opportunity for the sponsor to share