Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 3424

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 3424
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    or biologic will be produced to assess compliance with Current Good Manufacturing Practices, or cGMP, requirements to assure that
    the facilities, methods and controls are adequate to preserve the drug or biologic’s identity, strength, quality and purity;

    ●
    potential
    FDA audit of the clinical trial sites that generated the data in support of the NDA or BLA;

    ●
    payment
    of user fees for FDA review of the NDA or BLA; and

    ●
    FDA
    review and approval of the NDA or BLA, including consideration of the views of any FDA advisory committee, prior to any commercial
    marketing or sale of the drug or biologic in the United States.

48

The
preclinical and clinical testing and approval process requires substantial time, effort and financial resources, and the regulatory scheme
for drugs and biologics is evolving and subject to change at any time. We cannot be certain that any approvals for our product candidates
will be granted on a timely basis, or at all.

Preclinical
Studies

Before
testing any drug or biologic product candidate in humans, the product candidate must undergo rigorous preclinical testing. Preclinical
studies include laboratory evaluation of product chemistry, stability and formulation, as well as in vitro and animal studies to assess
safety and in some cases to establish a rationale for therapeutic use. The conduct of preclinical studies is subject to federal and state
regulations and requirements, including GLP regulations for safety/toxicology studies.

An
IND sponsor must submit the results of the preclinical studies, together with manufacturing information, analytical data, any available
clinical data or literature and plans for clinical trials, among other 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