Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 74

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 74
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 for some or all of the requirements for a diversity action plan. If the FDA objects to
a sponsor’s proposed diversity action plan, it may delay trial initiation.

16

Progress reports detailing the results of the clinical
trials must be submitted at least annually to the FDA and more frequently if serious adverse events occur. The FDA or the sponsor may
suspend or terminate a clinical trial at any time on various grounds, including a finding that the research subjects or patients are being
exposed to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if
the clinical trial is not being conducted in accordance with the clinical protocol, GCP, or other IRB requirements or if the drug has
been associated with unexpected serious harm to patients.

Marketing Application Submission and FDA Review

Assuming successful completion of the required
clinical testing, the results of the preclinical studies and clinical trials, along with the information relating to the product’s
chemistry, manufacturing and controls and proposed labeling, are submitted to the FDA as part of an NDA requesting approval to market
the product for one or more indications. The NDA must contain proof of the drug candidate’s safety and substantial evidence of effectiveness
for its proposed indication or indications in the form of relevant data available from pertinent preclinical and clinical studies, including
negative or ambiguous results as well as positive findings, together with detailed information relating to the product’s chemistry,
manufacturing, controls, and proposed labeling, among other things. In particular, a marketing application must demonstrate that the manufacturing
methods and quality controls used to produce the drug product are adequate to preserve the drug’s identity, strength, quality, and
purity. Data can come from company-sponsored clinical trials intended to test the safety and effectiveness of a use of the product, or
from a number of alternative sources, including studies initiated by investigators. FDA approval of an NDA must be obtained before the
corresponding drug may be marketed in the United States.

Under the Prescription Drug User Fee Act (“PDUFA”),
each NDA submission is subject to a substantial application user fee, and the sponsor of an approved NDA is also subject to an annual
program fee. The FDA adjusts the PDUFA user fees on an annual basis. The application user fee must be paid at the time of the first submission
of the application, even if the application is being submitted on a rolling basis. Fee waivers or reductions are available in certain
circumstances, including a