Company: CERO
Filing Date: 2025-02-07
Form Type: 424B3
Source: 0001213900-25-011071
Chunk: 78

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-07
Form: 424B3
Chunk 78
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 specific indication for which it
is being studied. The sponsor of a new biologic may request that the FDA designate the biologic as a fast track product at any time during
the clinical development of the product. For fast track products, sponsors may have greater interactions with the FDA during product
development. A fast track product may also be eligible for rolling review, where the FDA may consider for review sections of the BLA
on a rolling basis before the complete application is submitted, if the sponsor provides a schedule for the submission of the sections
of the BLA, the FDA agrees to accept sections of the BLA and determines that the schedule is acceptable, and the sponsor pays any required
user fees upon submission of the first section of the BLA. However, the FDA’s goal for reviewing a BLA fast track application
under the PDUFA does not begin until the last section of the application is submitted. Fast track designation may be withdrawn by the
FDA if the FDA believes that the designation is no longer supported by data emerging in the clinical trial process.

A breakthrough therapy is
defined as a product candidate that is intended, alone or in combination with one or more other drugs, to treat a serious or life-threatening
disease or condition, and preliminary clinical evidence indicates that the product candidate may demonstrate substantial improvement
over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical
development. For product candidates that have been designated as breakthrough therapies, interaction and communication between the FDA
and the sponsor of the trial can help to identify the most efficient path for clinical development while minimizing the number of patients
placed in ineffective control regimens. Product candidates designated as breakthrough therapies by the FDA are also eligible for priority
review if supported by clinical data at the time of the submission of the BLA.

Fast track designation,
priority review, and breakthrough therapy designation are within the discretion of the FDA. Accordingly, even if we believe that
one of our product candidates meets the criteria for any such designation, the FDA may disagree and instead determine not to make such
designation. In any event, the receipt of such designation may expedite the development or approval process, but do not change the standards
for approval. Even if a product qualifies for one or more of these programs, the FDA may later decide that the product no longer meets
the conditions for qualification or decide that the time period for FDA review or approval will not be shortened.

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We may seek approval