Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2533

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2533
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ologic for one or more specified indications and must contain proof of safety and efficacy
for a drug or safety, purity and potency for a biologic. The application may include both negative and ambiguous results of preclinical
studies and clinical trials, as well as positive findings. Data may come from company-sponsored clinical trials intended to test the
safety and efficacy of a product’s use or from a number of alternative sources, including studies initiated by investigators. To
support marketing approval, the data submitted must be sufficient in quality and quantity to establish the safety and efficacy of the
investigational product to the satisfaction of FDA. FDA approval of an NDA or BLA must be obtained before a drug or biologic may be marketed
in the United States.

Under
the Prescription Drug User Fee Act, or PDUFA, as amended, each NDA or BLA must be accompanied by a user fee. FDA adjusts the PDUFA user
fees on an annual basis. Fee waivers or reductions are available in certain circumstances, including a waiver of the application fee
for the first application filed by a small business. Additionally, no user fees are assessed on NDAs or BLAs for products designated
as orphan drugs, unless the product also includes a non-orphan indication.

50

The
FDA reviews all submitted NDAs and BLAs to ensure they are sufficiently complete to permit substantive review before it accepts them
for filing, and may request additional information rather than accepting the NDA or BLA for filing. The FDA must make a decision on accepting
an NDA or BLA for filing within 60 days of receipt, and such decision could include a refusal to file by the FDA. Once the submission
is accepted for filing, the FDA begins an in-depth review of the NDA or BLA. Under the goals and policies agreed to by the FDA under
PDUFA, the FDA targets ten months, from the filing date, in which to complete its initial review of a new molecular entity NDA or original
BLA and respond to the applicant, and six months from the filing date of a new molecular entity NDA or original BLA designated for priority
review. The FDA does not always meet its PDUFA goal dates for standard and priority NDAs or BLAs, and the review process is often extended
by FDA requests for additional information or clarification.

Before
approving an NDA or BLA, the FDA will conduct a pre-approval inspection of the manufacturing facilities for the new product to