Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2529

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2529
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 by an Institutional Review Board, or IRB, or independent ethics committee at each clinical trial site before each human trial may
    be initiated;

    ●
    performance
    of adequate and well-controlled human clinical trials in accordance with applicable IND regulations, GCP requirements and other clinical
    trial-related regulations to establish the safety and efficacy of the investigational product for each proposed indication;

    ●
    preparation
    and submission to the FDA of an NDA or BLA;

    ●
    a
    determination by the FDA within 60 days of its receipt of an NDA or BLA to file the application for review;

    ●
    satisfactory
    completion of one or more FDA pre-approval or pre-license inspections of the manufacturing facility or facilities where the drug
    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