Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 77

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 77
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 and statistical approach, or a justification for not including such
detailed information, and any request for a deferral of pediatric assessments or a full or partial waiver of the requirement to provide
data from pediatric studies along with supporting information. The FDA and the sponsor must reach an agreement on the PSP. A sponsor can
submit amendments to an agreed upon initial PSP at any time if changes to the pediatric plan need to be considered based on data collected
from preclinical studies, early-phase clinical trials or other clinical development programs.

The approval process is lengthy and often difficult,
and the FDA may refuse to approve an NDA if the applicable regulatory criteria are not satisfied or may require additional clinical or
other data and information. On the basis of the FDA’s evaluation of the NDA and accompanying information, including the results
of the inspection of the manufacturing facilities, the FDA may issue either an approval letter or a Complete Response Letter (“CRL”).
An approval letter authorizes commercial marketing of the product with specific prescribing information for specific indications. A CRL
indicates that the review cycle of the application is complete, and the application will not be approved in its present form. A CRL generally
outlines the deficiencies in the submission and may require substantial additional testing or information in order for the FDA to reconsider
the application. The CRL may require additional clinical or other data, additional pivotal Phase 3 clinical trial(s) and/or other significant
and time-consuming requirements related to clinical trials, nonclinical studies or manufacturing. If a CRL is issued, the applicant may
choose to either resubmit the NDA addressing all of the deficiencies identified in the letter or withdraw the application. If and when
those deficiencies have been addressed to the FDA’s satisfaction in a resubmission of the NDA, the FDA will issue an approval letter.
The FDA has committed to reviewing such resubmissions in response to an issued CRL in either two or six months depending on the type of
information included. Even with the submission of this additional information, however, the FDA ultimately may decide that the application
does not satisfy the regulatory criteria for approval.

If a product receives regulatory approval from
the FDA, the approval is limited to the conditions of use (e.g., patient population, indication) described in the application. Further,
depending on the specific risk(s) to be addressed, the FDA may require that contraindications, warnings or precautions be included in
the product labeling, require that post-approval trials, including Phase