Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2123

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 2123
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 Food, Drug, and Cosmetic Act, or FD&C Act, and its implementing regulations
and biologics under the FD&C Act and the Public Health Service Act, or PHSA, and their implementing regulations. Both drugs and biologics
also are subject to other federal, state and local statutes and regulations, such as those related to competition. The process of obtaining
regulatory approvals and the subsequent compliance with appropriate federal, state, and local statutes and regulations requires the expenditure
of substantial time and financial resources. Failure to comply with the applicable United States requirements at any time during the
product development process, approval process or following approval may subject an applicant to administrative actions or judicial sanctions.
These actions and sanctions could include, among other actions, the FDA’s refusal to approve pending applications, withdrawal of
an approval, license revocation, a clinical hold, untitled or warning letters, voluntary or mandatory product recalls or market withdrawals,
product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution,
disgorgement and civil or criminal fines or penalties. Any agency or judicial enforcement action could have a material adverse effect
on our business, the market acceptance of our products and our reputation.

Our
product candidates must be approved by the FDA through either an NDA or a BLA before they may be legally marketed in the United States.
The process generally involves the following:

    ●
    completion
    of extensive preclinical studies in accordance with applicable regulations, including studies conducted in accordance with GLP requirements;

    ●
    submission
    to the FDA of an IND application, which must become effective before human clinical trials may begin;

    ●
    approval
    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