Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 130

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 130
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 commencing clinical testing of biological products. FDA licensure also must be obtained before marketing
of biological products. The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local,
and foreign statutes and regulations require the expenditure of substantial time and financial resources.

U.S. Development Process

The process required by the FDA before a biological
product may be marketed in the United States generally involves the following:

●completion of nonclinical laboratory tests and animal studies according to Good Laboratory Practices (“GLPs”) and applicable
requirements for the humane use of laboratory animals or other applicable regulations;

●preparation of clinical trial material in accordance with cGMPs;

●submission to the FDA of an application for an IND application, which must become effective before human clinical trials may begin;

●approval by an institutional review board (“IRB”), reviewing each clinical site before each clinical trial may be initiated;

●performance of adequate and well-controlled human clinical trials according to Good Clinical Practice (“GCP”) requirements
and any additional requirements for the protection of human research subjects and their health information, to establish the safety, purity,
potency, and efficacy, of the proposed biological product for its intended use;

●submission to the FDA of a Biologics License Application (“BLA”) for marketing approval that includes substantive evidence
of safety, purity, potency, and efficacy from results of nonclinical testing and clinical trials;

●satisfactory completion of an FDA inspection prior to BLA approval of the manufacturing facility or facilities where the biological
product is produced to assess compliance with cGMPs, to assure that the facilities, methods, and controls are adequate to preserve the
biologic’s identity, strength, quality, and purity;

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●potential FDA audit of the nonclinical and clinical study sites that generated the data in support of the BLA;

●potential FDA advisory committee meeting to elicit expert input on critical issues and including a vote by external committee members;

●FDA review and approval, or licensure, of the BLA, and payment of associated user fees, when applicable; and

●compliance with any post-approval requirements, including the potential requirement to implement a Risk Evaluation and Mitigation
Strategy (“REMS”), and the potential requirement to conduct post approval studies.

Before testing any biological
product candidate in humans, the product candidate enters the preclinical testing stage. Nonclinical tests include laboratory evaluations
of product chemistry, pharmacology, toxicity, and formulation, as well as animal studies to assess the potential safety and activity