Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 78

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 78
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4 clinical trials, be conducted to further assess a product’s
safety after approval, require testing and surveillance programs to monitor the product after commercialization, or impose other conditions,
including distribution and use restrictions or other risk management mechanisms under a REMS, which can materially affect the potential
market and profitability of the product. The FDA may prevent or limit further marketing of a product based on the results of post-marketing
trials or surveillance programs. After approval, some types of changes to the approved product, such as adding new indications, manufacturing
changes and additional labeling claims, are subject to further testing requirements and FDA review and approval.

18

Fast Track, Priority Review, and Breakthrough Therapy Designations

A sponsor may seek approval of its drug candidate
under programs designed to accelerate the FDA’s review and approval of new drugs that meet certain criteria. Specifically, new drugs
are eligible for Fast Track designation if they are intended to treat a serious or life-threatening condition and demonstrate the potential
to address unmet medical needs for the condition. Fast Track designation provides increased opportunities for sponsor interactions with
the FDA during preclinical and clinical development, in addition to the potential for rolling review once a marketing application is filed,
meaning that the FDA may consider for review sections of the NDA on a rolling basis before the complete application is submitted, if the
sponsor provides a schedule for the submission of the sections of the application, the FDA agrees to accept the sections and determines
that the schedule is acceptable, and the sponsor pays any required user fees upon submission of the first section of the application.
A fast track designated drug candidate may also qualify for accelerated approval (described below) or priority review, under which the
FDA sets the target date for FDA action on an NDA at six months after the FDA accepts the application for filing.

Priority review is granted when there is evidence
that the proposed product would be a significant improvement in the safety or effectiveness of the treatment, diagnosis, or prevention
of a serious condition. Significant improvement may be illustrated by evidence of increased effectiveness in the treatment of a condition,
elimination or substantial reduction of a treatment-limiting drug reaction, documented enhancement of patient compliance that may lead
to improvement in serious outcomes, or evidence of safety and effectiveness in a new subpopulation. If criteria are not met for priority
review, the application is subject to the standard FDA review period of ten months after FDA accepts the application for filing.

In addition, a sponsor may seek FDA designation
of its drug candidate as a breakthrough