Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2530

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2530
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 things, to the FDA as part of an IND. An IND is a request for
authorization from the FDA to administer an investigational product to humans, and must become effective before human clinical trials
may begin in the United States. Some long-term preclinical testing, such as animal tests of reproductive adverse events and carcinogenicity,
may continue after the IND is submitted. An IND automatically becomes effective 30 days after receipt by the FDA, unless before that
time, the FDA raises concerns or questions related to one or more proposed clinical trials and places the trial on clinical hold. In
such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin in the United States.
As a result, submission of an IND may not result in the FDA allowing 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