Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2588

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2588
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 primary and/or secondary endpoint(s)) or to have unacceptable side effects or toxicities, or unexpected adverse drug-drug
    interactions;

    ●
    failure
    to establish clinical endpoints that applicable regulatory authorities would consider clinically meaningful;

    ●
    failure
    to execute the clinical trials caused by slow enrollment or subjects dropping out;

    ●
    failure
    to receive the necessary regulatory approvals;

    ●
    manufacturing
    costs, formulation issues, pricing or reimbursement issues, or other factors that make a product candidate uneconomical; and

    ●
    the
    proprietary rights of others and their competing products and technologies that may prevent one of our product candidates from being
    commercialized.

79

In
addition, differences in trial design between early-stage clinical trials and later-stage clinical trials make it difficult to extrapolate
the results of earlier clinical trials to later clinical trials. Moreover, clinical data are often susceptible to varying interpretations
and analyses, and many companies that have believed their product candidates performed satisfactorily in clinical trials have nonetheless
failed to obtain marketing approval of their products. Additionally, some of our trials may be open-label studies, where both the patient
and investigator know whether the patient is receiving the investigational product candidate or either an existing approved drug or placebo.
Most typically, open-label clinical trials test only the investigational product candidate and sometimes do so at different dose levels.
Open-label clinical trials are subject to various limitations that may exaggerate any therapeutic effect, such as “patient bias”
where patients in open-label clinical trials perceive their symptoms to have improved merely due to their awareness of receiving treatment.
Moreover, patients selected for early clinical studies often include the most severe sufferers and their symptoms may have been bound
to improve notwithstanding the new treatment. In addition, open-label clinical trials may be subject to an “investigator bias”
where those assessing and reviewing the physiological outcomes of the clinical trials are aware of which patients have received treatment
and may interpret the information of the treated group more favorably given this knowledge. Therefore, it is possible that positive results
observed in open-label trials will not be replicated in later placebo-controlled trials.

In
addition, the standards that the FDA and comparable foreign regulatory authorities use when regulating us require judgment and can change,
which makes it difficult to predict with certainty how they will be applied. The standards are also different for the development of
small molecule drug products and for the development of biological products, both of which we are undertaking through our programs.