Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2537

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2537
---
 ideally no later than the pre-NDA
or pre-BLA meeting.

A
product submitted to the FDA for marketing, including under a fast track program, may be eligible for other types of FDA programs intended
to expedite development or review, such as priority review and accelerated approval. Priority review means that, for a new molecular
entity or original BLA, the FDA sets a target date for FDA action on the marketing application at six months after accepting the application
for filing as opposed to ten months. A product is eligible for priority review if it is designed to treat a serious or life-threatening
disease condition and, if approved, would provide a significant improvement in safety and effectiveness compared to available therapies.
The FDA will attempt to direct additional resources to the evaluation of an application for a new drug or biologic designated for priority
review in an effort to facilitate the review. If criteria are not met for priority review, the application for a new molecular entity
or original BLA is subject to the standard FDA review period of ten months after FDA accepts the application for filing. Priority review
designation does not change the scientific/medical standard for approval or the quality of evidence necessary to support approval.

A
product may also be eligible for accelerated approval if it is designed to treat a serious or life-threatening disease or condition and
demonstrates an effect on either a surrogate endpoint that is reasonably likely to predict clinical benefit or on a clinical endpoint
that can be measured earlier than irreversible morbidity or mortality, or IMM, that is reasonably likely to predict an effect on IMM
or other clinical benefit, taking into account the severity, rarity, or prevalence of the disease or condition and the availability or
lack of alternative treatments. As a condition of approval, the FDA requires that a sponsor of a drug or biologic receiving accelerated
approval perform adequate and well-controlled post-marketing clinical trials. In addition, the FDA currently requires as a condition
for accelerated approval pre-approval of promotional materials, which could adversely impact the timing of the commercial launch of the
product. FDA may withdraw approval of a drug or indication approved under accelerated approval if, for example, the confirmatory trial
fails to verify the predicted clinical benefit of the product.

52

Additionally,
a drug or biologic may be eligible for designation as a breakthrough therapy if the product candidate is intended, alone or in combination
with one or more other drugs or biologics, to treat a serious or life-threatening condition and preliminary clinical evidence indicates
that the product candidate