Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 133

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 133
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 2, and Phase 3 clinical trials may not be completed successfully within any specified
period, if at all. The FDA or the sponsor or its data safety monitoring board may suspend a clinical trial at any time on various grounds,
including a finding that the research subjects or patients are being exposed to an unacceptable health risk. Similarly, an IRB can suspend
or terminate approval of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the IRB’s
requirements or if the biologic has been associated with unexpected serious harm to patients.

Concurrent with clinical
trials, companies usually complete additional animal studies and must also develop additional information about the physical characteristics
of the biologic as well as finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements.
To help reduce the risk of the introduction of adventitious agents with use of biologics, the PHS Act emphasizes the importance of manufacturing
control for products whose attributes cannot be precisely defined. The manufacturing process must be capable of consistently producing
quality batches of the product candidate and, among other things, the sponsor must develop methods for testing the identity, strength,
quality, potency, and purity of the final biological product. Additionally, appropriate packaging must be selected and tested and stability
studies must be conducted to demonstrate that the biological product candidate does not undergo unacceptable deterioration over its shelf
life.

There are also various laws
and regulations regarding laboratory practices, the experimental use of animals, and the use and disposal of hazardous or potentially
hazardous substances in connection with the research. In each of these areas, the FDA and other regulatory authorities have broad regulatory
and enforcement powers, including the ability to levy fines and civil penalties, suspend or delay issuance of approvals, seize or recall
products, and withdraw approvals.

Information about certain
clinical trials must be submitted within specific timeframes for public dissemination on the clinicaltrials.gov website. Sponsors or distributors
of investigational products for the diagnosis, monitoring, or treatment of one or more serious diseases or conditions must also have a
publicly available policy on evaluating and responding to requests for expanded access requests.

25

U.S. Review and Approval Processes

After the completion of clinical
trials of a biological product, FDA approval of a BLA must be obtained before commercial marketing of the product begins. The BLA must
include results of product development, laboratory, and animal studies, human studies, information on the manufacture and composition
of the product, proposed labeling