Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 142

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 142
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trial authorization in up to 30 EU/EEA countries at the same time and with a single set of documentation.

The assessment of applications
for clinical trials is divided into two parts (Part I contains scientific and medicinal product documentation and Part II contains the
national and patient-level documentation). Part I is assessed by a coordinated review by the competent authorities of all European Union
member states in which an application for authorization of a clinical trial has been submitted (Member States concerned) of a draft report
prepared by a reference Member State. Part II is assessed separately by each Member State concerned. The role of the relevant ethics committees
in the assessment procedure continues to be governed by the national law of the Member State concerned, however overall related timelines
are defined by the Clinical Trials Regulation. The Clinical Trials Regulation also provides for simplified reporting procedures for clinical
trial sponsors.

In addition, whether or not
we obtain FDA approval for a product, we must obtain approval of a product by the comparable regulatory authorities of countries outside
the United States before we can commence marketing of the product in those countries. The approval process and requirements vary from
country to country, so the number and type of nonclinical, clinical, and manufacturing studies needed may differ, and the time may be
longer or shorter than that required for FDA approval.

To obtain regulatory approval
of our medicinal products under the European Union regulatory system, we are required to submit a marketing authorization application
(“MAA”), to be assessed in the centralized procedure. The centralized procedure allows applicants to obtain a marketing authorization
(“MA”) that is valid throughout the European Union, and the additional countries of the European Economic Area (Iceland, Liechtenstein
and Norway) (“EEA”). It is compulsory for medicinal products manufactured using biotechnological processes, orphan medicinal
products, advanced therapy medicinal products (gene-therapy, somatic cell-therapy or tissue-engineered medicines) and medicinal products
containing a new active substance which is not authorized in the European Union and which is intended for the treatment of HIV, AIDS,
cancer, neurodegenerative disorders, auto-immune and other immune dysfunctions, viral diseases or diabetes. The centralized procedure
is optional for any other products containing new active substances not authorized in the European Union or for products which constitute
a significant therapeutic, scientific, or technical innovation or for which a centralized authorization is in the interests of public
health at European Union level. When a company wishes to place on the market a medicinal product that is eligible