Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 76

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 76
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 a REMS is necessary to ensure
that the benefits of the drug outweigh its risks and to assure the safe use of the product. The REMS could include medication guides,
physician communication plans, assessment plans and/or elements to assure safe use, such as restricted distribution methods, patient registries
or other risk minimization tools. The FDA determines the requirement for a REMS, as well as the specific REMS provisions, on a case-by-case
basis. If the FDA concludes a REMS is needed, the sponsor of the NDA must submit a proposed REMS. The FDA will not approve an NDA without
a REMS, if required.

17

Before approving an NDA, the FDA will typically
inspect the facility or facilities where the product is manufactured. The FDA will not approve an application unless it determines that
the manufacturing processes and facilities are in compliance with cGMP requirements and adequate to assure consistent manufacture of the
product within required specifications. Additionally, before approving an NDA, the FDA will typically inspect one or more clinical sites
to assure compliance with GCP. If the FDA determines that the application, manufacturing process or manufacturing facilities are not acceptable,
it will outline the deficiencies as part of the review process and often will request additional testing or information. Notwithstanding
the submission of any requested additional information, the FDA ultimately may decide that the application does not satisfy the regulatory
criteria for approval.

Under the Pediatric Research Equity Act (the “PREA”),
amendments to the FDCA, an NDA or supplement to an NDA must contain data that are adequate to assess the safety and efficacy of the drug
candidate for the claimed indications in all relevant pediatric populations and to support dosing and administration for each pediatric
population for which the product is safe and effective. The FDA may grant deferrals for submission of pediatric data or full or partial
waivers. The PREA requires a sponsor that is planning to submit a marketing application for a product that includes a new active ingredient,
new indication, new dosage form, new dosing regimen or new route of administration to submit an initial Pediatric Study Plan (“PSP”),
within 60 days of an end-of-Phase 2 meeting or, if there is no such meeting, as early as practicable before the initiation of the Phase
3 or Phase 2/3 clinical trial. The initial PSP must include an outline of the pediatric study or studies that the sponsor plans to conduct,
including trial objectives and design, age groups, relevant endpoints