Company: CERO
Filing Date: 2025-02-07
Form Type: 424B3
Source: 0001213900-25-011071
Chunk: 194

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-07
Form: 424B3
Chunk 194
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 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 Reconciliation Act of 2010 (collectively, the “Affordable Care Act”), created
an abbreviated approval pathway for biological products that are demonstrated to be “biosimilar” or “interchangeable”
with an FDA-licensed reference biological product via an approved BLA. Biosimilarity to an approved reference product requires that
there be no differences in conditions of use, route of administration, dosage form, and strength, and no clinically meaningful differences
between the biological product and the reference product in terms of safety, purity, and potency. Biosimilarity is demonstrated in steps
beginning with rigorous analytical studies or “fingerprinting”, in vitro studies, in vivo animal studies, and generally at
least one clinical study. If at any point in the stepwise biosimilarity process a significant difference is observed, then the products
are not biosimilar, and