Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 80

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 80
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 other measure that is thought to predict
clinical benefit, but is not itself a measure of clinical benefit. Surrogate endpoints can often be measured more easily or more rapidly
than clinical endpoints. An intermediate clinical endpoint is a measurement of a therapeutic effect that is considered reasonably likely
to predict the clinical benefit of a drug or biologic, such as an effect on IMM. The FDA has limited experience with accelerated approvals
based on intermediate clinical endpoints, but has indicated that such endpoints generally may support accelerated approval when the therapeutic
effect measured by the endpoint is not itself a clinical benefit and basis for traditional approval, if there is a basis for concluding
that the therapeutic effect is reasonably likely to predict the ultimate long-term clinical benefit of a drug.

19

The accelerated approval pathway is most often
used in settings in which the course of a disease is long, and an extended period of time is required to measure the intended clinical
benefit of a drug, even if the effect on the surrogate or intermediate clinical endpoint occurs rapidly. For example, accelerated approval
has been used extensively in the development and approval of drugs for treatment of a variety of cancers in which the goal of therapy
is generally to improve survival or decrease morbidity and the duration of the typical disease course requires lengthy and sometimes large
clinical trials to demonstrate a clinical or survival benefit.

The accelerated approval pathway is usually contingent
on a sponsor’s agreement to conduct, in a diligent manner, additional post-approval confirmatory studies to verify and describe
the drug candidate’s clinical benefit. As a result, a drug candidate approved on this basis is subject to rigorous post-marketing
compliance requirements, including the completion of Phase 4 or post-approval clinical trials to confirm the effect on the clinical endpoint.
Failure to conduct required post-approval studies, or to confirm the predicted clinical benefit of the product during post-marketing studies,
would allow the FDA to withdraw approval of the product. As part of the Consolidated Appropriations Act for 2023, Congress provided FDA
additional statutory authority to mitigate potential risks to patients from continued marketing of ineffective drugs or biologics previously
granted accelerated approval. Under such act’s amendments to the FDCA, the FDA may require the sponsor of a product granted accelerated
approval to have a confirmatory trial underway prior to approval. The sponsor must also submit progress reports on a confirmatory trial
every six months until the trial is complete, and such reports are published on FDA’s website. The amendments also give FDA the
option of using expedited