Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2125

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 2125
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 clinical trials to commence. Additionally, the review of information
in an IND application may prompt FDA to, among other things, scrutinize existing INDs or marketed products and could generate requests
for information or clinical holds on other product candidates or programs.

Clinical
Trials

The
clinical stage of development involves the administration of the investigational product to healthy volunteers or patients under the
supervision of qualified investigators, generally physicians not employed by or under the trial sponsor’s control, in accordance
with GCP requirements, which include the requirement that all research subjects provide their informed consent for their participation
in any clinical trial. Clinical trials are conducted under protocols detailing, among other things, the objectives of the clinical trial,
dosing procedures, subject selection and exclusion criteria and the parameters to be used to monitor subject safety and assess efficacy.
Each protocol, and any subsequent amendments to the protocol, must be submitted to the FDA as part of the IND. Furthermore, each clinical
trial must be reviewed and approved by an IRB for each institution at which the clinical trial will be conducted to ensure that the risks
to individuals participating in the clinical trials are minimized and are reasonable in relation to anticipated benefits. The IRB also
approves the informed consent form that must be provided to each clinical trial subject or his or her legal representative, and must
monitor the clinical trial until completed. There also are requirements governing the reporting of ongoing clinical trials and completed
clinical trial results to public registries. Information about certain clinical trials, including clinical trial results, must be submitted
within specific timeframes for publication on the www.clinicaltrials.gov website.

A
sponsor who wishes to conduct a clinical trial outside of the United States may, but need not, 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