Company: CERO
Filing Date: 2025-02-07
Form Type: 424B3
Source: 0001213900-25-011071
Chunk: 79

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-07
Form: 424B3
Chunk 79
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 of our product candidates, where applicable, under the FDA’s accelerated approval pathway. This pathway may not lead to a faster development, regulatory review or approval process and does not increase the likelihood that our product candidates will receive marketing approval.

A product may be eligible
for accelerated approval if it is designed to treat a serious or life-threatening disease or condition and generally provides a meaningful
advantage over available therapies upon a determination that the product candidate has an effect on a surrogate endpoint or intermediate
clinical endpoint that is reasonably likely to predict clinical benefit or on a clinical endpoint that can be measured earlier than irreversible
morbidity or mortality, (“IMM”) that is reasonably likely to predict an effect on IMM or other clinical benefit. The FDA
considers a clinical benefit to be a positive therapeutic effect that is clinically meaningful in the context of a given disease, such
as IMM. For the purposes of accelerated approval, a surrogate endpoint is a marker, such as a laboratory measurement, radiographic
image, physical sign or other measure that is thought to predict clinical benefit, but is not itself a measure of clinical benefit. An
intermediate clinical endpoint is a clinical endpoint that can be measured earlier than an effect on irreversible morbidity or mortality
that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit. The accelerated approval
pathway may be used in cases in which the advantage of a new drug over available therapy may not be a direct therapeutic advantage, but
is a clinically important improvement from a patient and public health perspective. If granted, accelerated approval is usually contingent
on the sponsor’s agreement to conduct, in a diligent manner, additional post-approval confirmatory studies to verity and describe
the drug’s clinical benefit. Under the FDORA, the FDA is permitted to require, as appropriate, that a post-approval confirmatory
study or studies be underway prior to approval or within a specified time period after the date of accelerated approval was granted.
FDORA also requires sponsors to send updates to the FDA every 180 days on the status of such studies, including progress toward
enrollment targets, and the FDA must promptly post this information publicly. FDORA also gives the FDA increased authority to withdraw
approval of a drug or biologic granted accelerated approval on an expedited basis if the sponsor fails to conduct such studies in a timely
manner, send the necessary updates to the FDA, or if such post-approval studies fail to verify the drug’s predicted clinical benefit.
Under FDORA, the FDA