Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 140

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 140
---
 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.

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 approval, the FDA generally requires, unless otherwise informed by the agency, that all advertising and promotional materials
intended for dissemination or publication within 120 days of marketing approval be submitted to the agency for review during the pre-approval
review period.

Moreover, a sponsor can request
designation of a product candidate as a “breakthrough therapy.” A breakthrough therapy is defined as a drug or biological
product that is intended, alone or in combination with one or more other drugs or biologics, to treat a serious or life-threatening disease
or condition, and preliminary clinical evidence indicates that the drug or biological product may demonstrate substantial improvement
over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical
development. Drug and biological products designated as breakthrough therapies are also eligible for accelerated approval. The FDA must
take certain actions, such as holding timely meetings and providing advice, intended to expedite the development and review of an application
for approval of a breakthrough therapy.

Even if a product qualifies
for one or more of these programs, the FDA may later decide that the product no longer meets the conditions for qualification or decides
that the time period for FDA review or approval will not be shortened. Furthermore, fast-track designation, priority review, accelerated
approval, and breakthrough therapy designation do not change the standards for approval and may not ultimately expedite the development
or approval process.

Biologics Price Competition and Innovation
Act

The Biologics Price Competition
and Innovation Act of 2009 (“BPCIA”), which was enacted as part of the Patient Protection and Affordable Care Act, as amended
by the Health Care and Education Re