Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2589

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2589
---
 Any
analysis we perform of data from preclinical and clinical activities is subject to confirmation and interpretation by regulatory authorities,
which could delay, limit or prevent regulatory approval. We may also encounter unexpected delays and/or increased costs due to new government
regulations. Examples of such regulations include future legislation or administrative action, or changes in FDA policy during the period
of product development and FDA regulatory review. It is impossible to predict whether legislative changes will be enacted, or whether
FDA or foreign regulations, guidance or interpretations will be changed, or what the impact of such changes, if any, may be. The FDA
may also require a panel of experts, referred to as an Advisory Committee, to deliberate on the adequacy of the safety and efficacy data
to support approval. The opinion of the Advisory 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