Company: CERO
Filing Date: 2025-02-07
Form Type: 424B3
Source: 0001213900-25-011071
Chunk: 80

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-07
Form: 424B3
Chunk 80
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 is empowered to take action, such as issuing fines, against companies that fail to conduct with due diligence any
post-approval confirmatory study or submit timely reports to the agency on their progress. In addition, the FDA currently requires, unless
otherwise informed by the agency, pre-approval of promotional materials for products receiving accelerated approval, which could adversely
impact the timing of the commercial launch of the product. Thus, even if we seek to utilize the accelerated approval pathway, we may
not be able to obtain accelerated approval and, even if we do, we may not experience a faster development, regulatory review or approval
process for that product. There can be no assurance that the FDA would allow any of the product candidates we may develop to proceed
on an accelerated approval pathway, and even if the FDA did allow such pathway, there can be no assurance that such submission or application
will be accepted or that any expedited development, review or approval will be granted on a timely basis, or at all. Moreover, even if
we received accelerated approval, any post-approval studies required to confirm and verify clinical benefit may not show such benefit,
which could lead to withdrawal of any approvals we have obtained. Receiving accelerated approval does not assure that the product’s
accelerated approval will eventually be converted to a traditional approval.

We may not be able to obtain orphan drug exclusivity for one or more of our product candidates, and even if we do, that exclusivity may not prevent the FDA from approving other competing products.

Regulatory authorities may
designate drugs for relatively small patient populations as “orphan” drugs. Generally, if a product with an orphan drug designation
subsequently receives the first marketing approval for the indication for which it has such designation, the product is entitled to a
period of market exclusivity, which, subject to certain exceptions, precludes the FDA from approving another marketing application for
the same drug for the same indication for that time period. The applicable market exclusivity period is seven years in the United States.

Obtaining orphan drug exclusivity
for our product candidates may be important to our commercial strategy. If a competitor obtains orphan drug exclusivity for and approval
of a product with the same indication as our product candidates before we do, and if the competitor’s product is the same drug
or a similar medicinal product as ours, we could be excluded from the market. Even if we obtain orphan drug exclusivity after FDA approval,
we may not be able to maintain it. For example, if