Company: CERO
Filing Date: 2025-02-07
Form Type: 424B3
Source: 0001213900-25-011071
Chunk: 193

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-07
Form: 424B3
Chunk 193
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 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.

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 prevalence of
the condition and the availability or lack of alternative treatments. As a condition of approval, the FDA may require a sponsor of a
biological product receiving accelerated approval to perform adequate and well-controlled post-marketing studies to verify and describe
the predicted effect on irreversible morbidity or mortality or other clinical endpoint. Under the Food and Drug Omnibus Reform Act of
2022 (“FDORA”), the FDA may require, as appropriate, that such trials be underway prior to approval or within a specific
time period after the date of approval for a product granted accelerated approval.

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Under FDORA, the FDA has
increased authority for expedited procedures to 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. In addition, for products being considered
for accelerated