Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2531

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2531
---
, obtain FDA authorization to conduct the
clinical trial under an IND. If a foreign clinical trial is not conducted under an IND, the sponsor may submit data from the clinical
trial to the FDA in support of an NDA or BLA. The FDA will accept a well-designed and well-conducted foreign clinical trial not conducted
under an IND if the study was conducted in accordance with GCP requirements, and the FDA is able to validate the data through an onsite
inspection if deemed necessary.

Clinical
trials generally are conducted in three sequential phases, known as Phase 1, Phase 2 and Phase 3, and may overlap.

    ●
    Phase
    1 clinical trials generally involve a small number of healthy volunteers or disease-affected patients who are initially exposed to
    a single dose and then multiple doses of the product candidate. The primary purpose of these clinical trials is to assess the metabolism,
    pharmacologic action, side effect tolerability and safety of the product candidate.

    ●
    Phase
    2 clinical trials involve studies in disease-affected patients to evaluate proof of concept and/or determine the dose required to
    produce the desired benefits. At the same time, safety and further pharmacokinetic and pharmacodynamic information is collected,
    possible adverse effects and safety risks are identified and a preliminary evaluation of efficacy is conducted.

49

    ●
    Phase
    3 clinical trials generally involve a large number of patients at multiple geographically dispersed clinical trial sites and are
    designed to provide the data necessary to demonstrate the effectiveness of the product for its intended use, its safety in use and
    to establish the overall benefit/risk relationship of the product and provide an adequate basis for approval and product labeling.

Post-approval
trials, sometimes referred to as Phase 4 clinical trials, 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 and are commonly intended to generate
additional safety data regarding use of the product in a clinical setting. In certain instances, the FDA may mandate the performance
of Phase 4 clinical trials as a condition of approval of an NDA or BLA. Failure to exhibit due diligence with regard to conducting required
Phase 4 clinical trials could result in withdrawal of approval for products.

Progress
reports detailing the results of the clinical trials, among other information, must be submitted at least annually to the FDA and written
IND safety reports must be submitted to the FDA and the investigators