Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 3426

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 3426
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 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.

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    ●
    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 15 days after the trial sponsor determines the information qualifies
for reporting for serious and unexpected suspected adverse events, findings from other studies or animal or in vitro testing that suggest
a significant risk for human subjects and any clinically important increase in the rate of a serious suspected adverse reaction over
that listed in the protocol or investigator brochure. The sponsor must also notify the FDA of any unexpected fatal or life-threatening
suspected adverse reaction as soon as possible but in no case later than seven calendar days after the sponsor’s initial receipt
of the information.

Phase
1, Phase 2, Phase 3 and other types of clinical trials may not be completed successfully within any specified period, if at all. The
FDA or the sponsor may suspend or terminate a clinical trial at any time on various grounds, including