Company: CERO
Filing Date: 2025-02-07
Form Type: 424B3
Source: 0001213900-25-011071
Chunk: 189

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-07
Form: 424B3
Chunk 189
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of relevant data and information, the FDA may ultimately decide that the BLA does not satisfy its regulatory criteria for approval and
deny approval. Data obtained from clinical trials are not always conclusive and the FDA may interpret data differently than the sponsor
interprets the same data. If the agency decides not to approve the BLA in its present form, the FDA will issue a complete response letter
that describes all of the specific deficiencies in the BLA identified by the FDA. The deficiencies identified may be minor, such
as requiring labeling changes, or major, such as requiring additional clinical trials. Additionally, the complete response letter may
include recommended actions that the applicant might take to place the application in a condition for approval. If a complete response
letter is issued, the applicant may either resubmit the BLA, addressing all of the deficiencies identified in the letter, or withdraw
the application.

If a product receives regulatory
approval, the approval may be significantly limited to specific diseases and dosages or the indications for use may otherwise be limited,
which could restrict the commercial value of the product. Further, the FDA may require that certain contraindications, warnings, or precautions
be included in the product labeling. The FDA may impose restrictions and conditions on product distribution, prescribing, or dispensing
in the form of a risk management plan, or otherwise limit the scope of any approval. In addition, the FDA may require post-marketing
clinical trials, sometimes referred to as Phase 4 clinical trials, designed to further assess a biological product’s safety
and effectiveness, and testing and surveillance programs to monitor the safety of approved products that have been commercialized. As
a condition for approval, the FDA may also require additional nonclinical testing as a Phase 4 commitment.

One of the performance goals
agreed to by the FDA under the PDUFA is to review standard BLAs in ten months from filing and priority BLAs in six months from
filing, whereupon a review decision is to be made. The FDA does not always meet its PDUFA goal dates for standard and priority BLAs and
its review goals are subject to change from time to time. The review process and the PDUFA goal date may be extended by three months
if the FDA requests or the BLA sponsor otherwise provides additional information or clarification regarding information already provided
in the submission within the last three months before the PDUFA goal date.

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Post-Approval Requirements

Maintaining substantial