Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2132

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 2132
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 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 may demonstrate substantial improvement over currently approved therapies on one or more clinically significant
endpoints, such as substantial treatment effects observed early in clinical development. If the FDA designates a breakthrough therapy,
it may take actions appropriate to expedite the development and review of the application, which may include holding meetings with the
sponsor and the review team throughout the development of the therapy; providing timely advice to, and interactive communication with,
the sponsor regarding the development of the drug to ensure that the development program to gather the nonclinical and clinical data
necessary for approval is as efficient as practicable; involving senior managers and experienced review staff, as appropriate, in a collaborative,
cross-disciplinary review; assigning a cross-disciplinary project lead for the FDA review team to facilitate an efficient review of the
development program and