Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 281

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1A
Chunk 281
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 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) over the last decade, certain brand-name pharmaceutical
companies and others have objected to the FDA’s interpretation of Section 505(b)(2). If the FDA’s interpretation of Section
505(b)(2) is successfully challenged, or Congress were to amend the statute to alter the currently available regulatory pathway, the
FDA may change its 505(b)(2) policies and practices, which could delay or even prevent the FDA from approving any NDA we submit under
Section 505(b)(2). In addition, the pharmaceutical industry is highly competitive, and Section 505(b)(2) NDAs are subject to special
requirements designed to protect the patent rights of sponsors of previously approved drugs referenced in a Section 505