Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 75

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 75
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 waiver of the application fee for the first application filed by a small business.

The FDA reviews all NDAs submitted to determine
if they are substantially complete before it accepts them for filing and may request additional information rather than accepting a submission
for filing. The FDA must make a decision on accepting an NDA for filing within 60 days of receipt and must inform the sponsor by the 74th
day after the FDA’s receipt of the submission whether the application is sufficiently complete to permit substantive review. The
FDA may refuse to file any submission that it deems incomplete or not properly reviewable at the time of submission and may request additional
information. In this event, the marketing application must be resubmitted with the additional information requested by the agency. The
resubmitted application is also subject to review before the FDA accepts it for filing.

Once an NDA is accepted for filing, the FDA’s
goal is to review the application within ten months after it accepts the application for filing, or, if the application meets the criteria
for “priority review,” six months after the FDA accepts the application for filing. The review process is often significantly
extended by FDA requests for additional information or clarification after the NDA has been accepted for filing. The review process may
be extended by the FDA for three additional months to consider new information or in the case of a clarification provided by the applicant
to address an outstanding deficiency identified by the FDA following the original submission.

During the review process, the FDA reviews the
NDA to determine, among other things, whether the product is safe and effective and whether the facility in which it is manufactured,
processed, packed, or held meets standards designed to assure the product’s continued strength, quality, and purity. The FDA may
refer any NDA, including applications for novel drug candidates which present difficult questions of safety or efficacy to an advisory
committee to provide clinical insight on application review questions. Typically, an advisory committee is a panel of independent experts,
including clinicians and other scientific experts that reviews and evaluates the application and provides a recommendation as to whether
it should be approved and under what conditions. The FDA is not bound by the recommendation of an advisory committee, but it considers
such recommendations carefully when making final decisions on approval.

The FDA likely will re-analyze the clinical trial
data, which could result in extensive discussions between the FDA and the applicant during the review process. The FDA also may require
the development of a risk evaluation and mitigation strategy (“REMS”), if it determines that