Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2184

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 2184
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 Committee, although not binding, may have a significant impact on our ability to obtain
approval of any product candidates that we develop.

If
we seek to conduct clinical trials in foreign countries or pursue marketing approvals in foreign jurisdictions, we must comply with numerous
foreign regulatory requirements governing, among other things, the conduct of clinical trials, manufacturing and marketing authorization,
pricing and third-party reimbursement. The foreign regulatory approval process varies among countries and may include all of the risks
associated with FDA approval described above as well as risks attributable to the satisfaction of local regulations in foreign jurisdictions.
Moreover, the time required to obtain approval may differ from that required to obtain FDA approval. Approval by the FDA does not ensure
approval by regulatory authorities outside the United States and vice versa.

The
acceptance of study data from clinical trials conducted outside the United States or another jurisdiction by the FDA or comparable foreign
regulatory authority may be subject to certain conditions or may not be accepted at all. If data from foreign clinical trials are intended
to serve as the basis for marketing approval in the United States, the FDA will generally not approve the application on the basis of
foreign data alone unless (i) the data are applicable to the U.S. population and U.S. medical practice, and (ii) the trials were performed
by clinical investigators of recognized competence and pursuant to good clinical practice, or GCP, regulations. Additionally, the FDA’s
clinical trial requirements, including sufficient size of patient populations and statistical powering, must be met. Many foreign regulatory
authorities have similar approval requirements.

Successful
completion of clinical trials is a prerequisite to submitting a marketing application to the FDA and similar marketing applications to
comparable foreign regulatory authorities, for each product candidate and, consequently, the ultimate approval and commercial marketing
of any product candidates. We may experience negative or inconclusive results, which may result in our deciding, or our being required
by regulators, to conduct additional clinical studies or trials or abandon some or all of our product development programs, which could
have a material adverse effect on our business.

We
may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development of any of our product
candidates.

80

We
may experience delays in initiating or completing clinical trials. Clinical trials can be delayed or terminated for a variety of reasons,
including:

    ●
    regulators
    or institutional review boards, or IRBs, or ethics committees may not authorize us or our investigators to commence a clinical trial
    or conduct