Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 1652

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1A
Chunk 1652
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We may seek fast track and breakthrough
therapy designations or priority review for one or more of our product candidates, but we might not receive such designation or priority
review, and even if we do, such designation or priority review may not lead to a faster development or regulatory review or approval process,
and does not assure FDA approval of our product candidates. Even if a product qualifies for such designation or priority review, 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.

We may seek fast track, breakthrough
therapy, and/or regenerative medicine advanced therapy designations or priority review for one or more of our product candidates.

The FDA may issue a fast
track designation to a product candidate if it is intended, whether alone or in combination with one or more other products, for the treatment
of a serious or life-threatening disease or condition, and it demonstrates the potential to address unmet medical needs for such a disease
or condition. Fast track designation applies to the combination of the product and the 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 Fast track designation may be withdrawn by the FDA if the FDA believes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