Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2131

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 2131
---
 BLA. Applications also must contain reports of one or more new clinical investigations (other than bioavailability studies)
that were essential to the approval of the application and conducted or sponsored by the sponsor. In addition, the sponsor must provide
in the application an attestation that such report(s) were not submitted as part of an application for marketing approval or licensure
by a regulatory authority in India, Brazil, Thailand, or any country that is a member of the Pharmaceutical Inspection Convention or
the Pharmaceutical Inspection Cooperation Scheme prior to September 27, 2007.

Expedited
Development and Review Programs

A
sponsor may seek to develop and obtain approval of its product candidates under programs designed to accelerate the development, FDA
review and approval of new drugs and biologics that meet certain criteria. For example, the FDA has a fast track program that is intended
to expedite or facilitate the process for reviewing new drugs and biologics that are intended to treat a serious or life threatening
disease or condition and demonstrate the potential to address unmet medical needs for the condition. Fast track designation applies to
both the product and the specific indication for which it is being studied. For a fast track-designated product, the FDA may consider
sections of the NDA or BLA for review on a rolling basis before the complete application is submitted, if the sponsor provides a schedule
for the submission of the sections of the application, the FDA agrees to accept sections of the application and determines that the schedule
is acceptable and the sponsor pays any required user fees upon submission of the first section of the application. The sponsor can request
the FDA to designate the product for fast track status any time before receiving NDA or BLA approval, but 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