Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 79

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 79
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 therapy if the drug candidate is intended, alone or in combination with one or more other drugs
or biologics, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the therapy
may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment
effects observed early in clinical development. Breakthrough therapy designation provides all the features of Fast Track designation in
addition to intensive guidance on an efficient development program beginning as early as Phase 1, and FDA organizational commitment to
expedited development, including involvement of senior managers and experienced review and regulatory staff in a proactive, collaborative,
cross-disciplinary review, where appropriate. A drug designated as breakthrough therapy is also eligible for accelerated approval if the
relevant criteria are met.

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. Fast track, priority review and breakthrough therapy designations do not change the
scientific or medical standards for approval or the quality of evidence necessary to support approval but may expedite the development
or approval process.

Accelerated Approval

In addition, products studied for their safety
and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit over existing treatments
may receive accelerated approval from the FDA and may be approved on the basis of adequate and well-controlled clinical trials establishing
that the drug product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit. The FDA may also grant
accelerated approval for such a drug or biologic when it has an effect on an intermediate clinical endpoint that can be measured earlier
than an effect on irreversible morbidity and mortality (“IMM”), and that is reasonably likely to predict an effect on IMM
or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative
treatments. As a condition of approval, the FDA may require that a sponsor of a drug receiving accelerated approval perform post-marketing
clinical trials to verify and describe the predicted effect on IMM or other clinical endpoint, and the product may be subject to expedited
withdrawal procedures. Drugs granted accelerated approval must meet the same statutory standards for safety and effectiveness as those
granted traditional approval.

For the purposes of accelerated approval, a surrogate
endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign, or