Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2129

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 2129
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analyze the clinical trial data, which could result in extensive
discussions between the FDA and the applicant during the review process. After the FDA evaluates an NDA or BLA, it will issue an approval
letter or a Complete Response Letter. An approval letter authorizes commercial marketing of the drug or biologic with specific prescribing
information for specific indications. A Complete Response Letter indicates that the review cycle of the application is complete and the
application will not be approved in its present form. A Complete Response Letter usually describes all of the specific deficiencies in
the NDA or BLA identified by the FDA. The Complete Response Letter may require the applicant to obtain additional clinical data, including
the potential requirement to conduct additional pivotal Phase 3 clinical trial(s) and/or to complete other significant and time-consuming
requirements related to clinical trials, or to conduct additional preclinical studies or manufacturing activities. If a Complete Response
Letter is issued, the applicant may either resubmit the NDA or BLA, addressing all of the deficiencies identified in the letter, or withdraw
the application or request an opportunity for a hearing. Even if such data and information are submitted, the FDA may decide that the
NDA or BLA does not satisfy the criteria for approval. Data obtained from clinical trials are not always conclusive and the FDA may interpret
data differently than we interpret the same data.

Orphan
Drug Designation and Exclusivity

Under
the Orphan Drug Act, the FDA may grant orphan designation to a drug or biological product intended to treat a rare disease or condition,
which is generally a disease or condition that affects fewer than 200,000 individuals in the United States, or more than 200,000 individuals
in the United States and for which there is no reasonable expectation that the cost of developing and making the product available in
the United States for this type of disease or condition will be recovered from sales of the product.

Orphan
drug designation must be requested before submitting an NDA or BLA. After the FDA grants orphan drug designation, the identity of the
therapeutic agent and its potential orphan use are disclosed publicly by the FDA. Orphan drug designation does not convey any advantage
in or shorten the duration of the regulatory review and approval process.

If
a product that has orphan drug designation subsequently receives the first FDA approval for the disease or condition for which it has
such designation, the product is entitled to orphan drug exclusivity, which means that the FDA may not approve any other applications
to market the