Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 138

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 138
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 we will receive marketing approval or that approval will be granted within any particular time frame.
We may not experience a faster development or regulatory review or approval process with Fast Track designation compared to conventional
FDA procedures. In addition, the FDA may withdraw Fast Track designation if the designation is no longer supported by data from our clinical
development program. Fast Track designation alone does not guarantee qualification for the FDA’s priority review procedures.

We
expect to utilize the FDA’s Section 505(b)(2) pathway for certain of our drug candidates and if that pathway is not available,
the development of our drug candidates will likely take significantly longer, cost significantly more and entail significantly greater
complexity and risk than currently anticipated, and, in any case, may not be successful.

We
plan to seek approval to use the FDA’s Section 505(b)(2) pathway for certain of our drug candidates. However, if the FDA subsequently
determines that we may not use this regulatory pathway, then we would need to seek regulatory approval for the drug candidates via a
“full” or “stand-alone” NDA under Section 505(b)(1) of the FDCA. This would require us to conduct additional
clinical trials, provide additional safety and efficacy data and other information, and meet additional standards for regulatory approval
including possibly nonclinical data. If this were to occur, the time and financial resources required to obtain FDA approval, as well
as the development complexity and risk associated with these programs, would likely substantially increase, which could have a material
adverse effect on our business and financial condition.

52

The
Drug Price Competition and Patent Term Restoration Act of 1984, informally known as the Hatch-Waxman Act, added Section 505(b)(2) to
the FDCA. Section 505(b)(2) permits the filing of an NDA where at least some of the information required for approval comes from studies
and information that were not conducted by or for the applicant and for which the applicant has not obtained a right of reference. Section
505(b)(2), if applicable to us under the FDCA, would allow an NDA we submit to the FDA to rely in part on data in the public domain or
the FDA’s prior conclusions regarding the safety and effectiveness of approved compounds, which could expedite our development
programs relative to seeking approval under the 505(b)(1) regulatory pathway.

Notwithstanding
the approval of an increasing number of products by the FDA under Section 505(b)(2