Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 283

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1A
Chunk 283
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isdictions. In cases where data from clinical trials conducted wholly outside of the United States are intended to serve as the basis
for marketing approval in the United States, the FDA will generally not accept such non-U.S. trial data unless (i) the data are determined
to be applicable to the U.S. population and U.S. medical practice; (ii) the trials were performed by clinical investigators of recognized
competence and pursuant to GCP regulations; and (iii) the FDA is able to validate the data through an onsite inspection or other appropriate
means, if necessary. Additionally, the FDA’s clinical trial requirements, including sufficient size of patient populations and
statistical powering, must be met. Furthermore, even where the non-U.S. trial data are not intended to serve as the sole basis for approval,
the FDA will not accept the data as support for an application for marketing approval unless the study is well-designed and well-conducted
in accordance with GCP requirements and the FDA is able to validate the data from the study through an onsite inspection if deemed necessary.
Many comparable non-U.S. regulatory authorities have similar approval requirements.

In
addition, while these clinical trials are subject to the applicable local laws, the FDA acceptance of the data will be dependent upon
its determination that the trials also complied with all applicable U.S. laws and regulations. There can be no assurance that the FDA
will accept future data from trials conducted outside of the United States. If the FDA does not accept the data from any of our clinical
trials that we determine to conduct or have conducted outside the United States, it would likely result in the need for additional trials
that would be costly and time-consuming and delay or permanently halt the development of a drug candidate.

Conducting
clinical trials outside the United States may also expose us to additional risks, including risks associated with the following, among
other things: additional international regulatory requirements; international exchange fluctuations; compliance with international manufacturing,
customs, shipment and storage requirements; the failure of enrolled subjects in international countries to adhere to clinical protocol
as a result of differences in standard-of-care; cultural differences in medical practice and clinical research; diminished protection
of intellectual property rights; and compliance with general local legal requirements.

53

Risks
Related to Commercialization of Our Drug Candidates

Even
if we receive marketing approval of a drug candidate, we will be subject to ongoing regulatory obligations and continued regulatory review,
which may result in significant additional expense and we may be subject to penalties if