Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2532

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2532
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15 days after the trial sponsor determines the information qualifies
for reporting for serious and unexpected suspected adverse events, findings from other studies or animal or in vitro testing that suggest
a significant risk for human subjects and any clinically important increase in the rate of a serious suspected adverse reaction over
that listed in the protocol or investigator brochure. The sponsor must also notify the FDA of any unexpected fatal or life-threatening
suspected adverse reaction as soon as possible but in no case later than seven calendar days after the sponsor’s initial receipt
of the information.

Phase
1, Phase 2, Phase 3 and other types of clinical trials may not be completed successfully within any specified period, if at all. The
FDA or the sponsor may suspend or terminate a clinical trial at any time on various grounds, including a finding that the research subjects
or patients are being exposed to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval of a clinical trial
at its institution if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the drug or biologic
has been associated with unexpected serious harm to patients. Additionally, some clinical trials are overseen by an independent group
of qualified experts organized by the clinical trial sponsor, known as a data safety monitoring board or committee. This group provides
authorization for whether a trial may move forward at designated check points based on access to certain data from the trial. Concurrent
with clinical trials, companies usually complete additional animal studies and also must develop additional information about the chemistry
and physical characteristics of the drug or biologic as well as finalize a process for manufacturing the product in commercial quantities
in accordance with cGMP requirements. The manufacturing process must be capable of consistently producing quality batches of the product
and, among other things, companies must develop methods for testing the identity, strength, quality and purity of the final product.
Additionally, appropriate packaging must be selected and tested and stability studies must be conducted to demonstrate that the product
candidates do not undergo unacceptable deterioration over their shelf life.

FDA
Review Process

Following
completion of the clinical trials, data are analyzed to assess whether the investigational product is safe and effective for the proposed
indicated use or uses. The results of preclinical studies and clinical trials are then submitted to the FDA as part of an NDA or BLA,
along with proposed labeling, chemistry and manufacturing information to ensure product quality and other relevant data. The NDA or BLA
is a request for approval to market the drug or bi