Company: CERO
Filing Date: 2025-02-07
Form Type: 424B3
Source: 0001213900-25-011071
Chunk: 192

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-07
Form: 424B3
Chunk 192
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the FDA may grant orphan drug designation (“ODD”), to a biological product intended to treat a rare disease or condition,
which is generally a disease or condition that affects fewer than 200,000 individuals in the United States, or more than 200,000
individuals in the United States and for which there is no reasonable expectation that the cost of developing and making a biological
product available in the United States for this type of disease or condition will be recovered from sales of the product. ODD must
be requested before submitting a BLA. After the FDA grants ODD, the identity of the therapeutic agent and its potential orphan use
are disclosed publicly by the FDA. ODD does not convey any advantage in or shorten the duration of the regulatory review and approval
process.

If a product that has ODD
receives the first FDA approval for the disease or condition for which it has such designation, the product is entitled to orphan product
exclusivity, which means that the FDA may not approve any other applications to market the same biological product for the same indication
for seven years, except in limited circumstances, such as not being able to supply the product for patients or showing clinical
superiority to the product with orphan exclusivity.

Competitors, however, may
receive approval of different products for the indication for which the orphan product has exclusivity or obtain approval for the same
product but for a different indication for which the orphan product has exclusivity. Orphan product exclusivity also could block the
approval of one of our products for seven years if a competitor obtains approval of the same biological product as defined by the
FDA or if our product 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