Company: CERO
Filing Date: 2025-02-07
Form Type: 424B3
Source: 0001213900-25-011071
Chunk: 196

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-07
Form: 424B3
Chunk 196
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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 Member States 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 patients at European Union level. When a company wishes to place on the market a medicinal product that is eligible for the centralized
procedure, it sends an application directly to the EMA, to be assessed by the Committee for Medicinal Products for Human Use (“CHMP”).
The CHMP is responsible for conducting the assessment of whether a medicine meets the required quality, safety, and efficacy requirements,
and whether the product has a positive risk/benefit profile. The procedure results in a European Commission decision, which is valid
in all European Union Member States. The centralized procedure is as follows: full copies of the MAA are sent to a rapporteur and a co-rapporteur
designated by the competent European Medicines Agency (“EMA”) scientific committee. They coordinate the EMA’s scientific
assessment of the medicinal product and prepare draft reports. Once the draft reports are prepared (other experts might