Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 139

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 139
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 candidate is determined to be contained within the competitor’s product for the same indication or disease. If a biological
product designated as an orphan product receives marketing approval for an indication broader than what is designated, it may not be entitled
to orphan product exclusivity.

Expedited Review and Approval Programs

The FDA has various programs,
including fast track designation, priority review, accelerated approval, and breakthrough therapy designation, that are intended to expedite
or simplify the process for the development and FDA review of biological products that are intended for the treatment of serious or life-threatening
diseases or conditions and demonstrate the potential to address unmet medical needs. The purpose of these programs is to provide important
new biological products to patients earlier than under standard FDA review procedures. To be eligible for a fast track designation, the
FDA must determine, based on the request of a sponsor, that a biological product is intended to treat a serious or life-threatening disease
or condition and demonstrates the potential to address an unmet medical need. The FDA will determine that a product will fill an unmet
medical need if it will provide a therapy where none exists or provide a therapy that may be potentially superior to existing therapy
based on efficacy or safety factors. In addition to other benefits, such as the ability to have greater interactions with the FDA, the
FDA may initiate review of sections of a fast track BLA before the application is complete, a process known as rolling review.

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The FDA may give a priority
review designation, such as a rare pediatric disease designation, to biological products that treat a serious condition and, if approved,
would provide a significant improvement in safety or effectiveness. A priority review means that the goal for the FDA to review an application
is six months, rather than the standard review of ten months under current PDUFA guidelines. Most products that are eligible for fast
track designation may also be considered appropriate to receive a priority review. In addition, biological products studied for their
safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit over existing
treatments may receive accelerated approval and may be approved on the basis of adequate and well-controlled clinical trials establishing
that the biological product has an effect on 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, that is reasonably likely to predict an effect on irreversible
morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or