Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2133

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 2133
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 to serve as a scientific liaison between the review team and the sponsor; and considering alternative clinical
trial designs when scientifically appropriate, which may result in smaller trials or more efficient trials that require less time to
complete and may minimize the number of patients exposed to a potentially less efficacious treatment. Breakthrough therapy designation
comes with all of the benefits of fast track designation, which means that the sponsor may file sections of the BLA for review on a rolling
basis if certain conditions are satisfied, including an agreement with the FDA on the proposed schedule for submission of portions of
the application and the payment of applicable user fees before the FDA may initiate a review.

Even
if a product qualifies for one or more of these programs, the FDA may later decide that the product no longer meets the conditions for
qualification or the time period for FDA review or approval may not be shortened. Furthermore, fast track designation, priority review,
accelerated approval and breakthrough therapy designation do not change the standards for approval.

Pediatric
Information and Pediatric Exclusivity

Under
the Pediatric Research Equity Act, or PREA, certain NDAs and BLAs and certain supplements to an NDA or BLA must contain data to assess
the safety and efficacy of the drug for the claimed indications in all relevant pediatric subpopulations and to support dosing and administration
for each pediatric subpopulation for which the product is safe and effective. The FDA may grant deferrals for submission of pediatric
data or full or partial waivers. The Food and Drug Administration Safety and Innovation Act, or FDASIA, amended the FD&C Act to require
that a sponsor who is planning to submit a marketing application for a drug that includes a new active ingredient, new indication, new
dosage form, new dosing regimen or new route of administration submit an initial Pediatric Study Plan, or PSP, within 60 days of an end-of-Phase
2 meeting or, if there is no such meeting, as early as practicable before the initiation of the Phase 3 or Phase 2/3 clinical trial.
The initial PSP must include an outline of the pediatric study or studies that the sponsor plans to conduct, including study objectives
and design, age groups, relevant endpoints and statistical approach, or a justification for not including such detailed information,
and any request for a deferral of pediatric assessments or a full or partial waiver of the requirement to provide data from pediatric
studies along with supporting information. The FDA and the sponsor must reach an agreement on the PSP. A sponsor