Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 3427

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 3427
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 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 biologic for one or more specified indications and must contain proof of safety and efficacy
for a drug or safety, purity and potency for a biologic. The application may include both negative and ambiguous results of preclinical
studies and clinical trials, as well as positive findings. Data may come from company-sponsored clinical trials intended to test the
safety and efficacy of a product’s use or from a number of alternative sources, including studies initiated by investigators. To
support marketing approval, the data submitted must be sufficient in quality and quantity to establish the safety and efficacy of the
investigational product to the satisfaction of FDA. FDA approval of an NDA or BLA must be obtained before a drug or biologic may be marketed
in the United States.

Under
the Prescription Drug User Fee