Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2534

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2534
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 determine
whether they comply with cGMP requirements. The FDA will not approve the product unless it determines that the manufacturing processes
and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within the required
specifications. The FDA also may audit data from clinical trials to ensure compliance with GCP requirements. Additionally, the FDA may
refer applications for novel products or products which present difficult questions of safety or efficacy to an advisory committee, typically
a panel that includes clinicians and other experts, for review, evaluation and a recommendation as to whether the application should
be approved and under what conditions, if any. The FDA is not bound by recommendations of an advisory committee, but it considers such
recommendations when making decisions on approval. The FDA likely will reanalyze 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