Company: MIRA
Filing Date: 2025-03-28
Form Type: 10-K
Source: 0001641172-25-001183
Chunk: 33

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-03-28
Form: 10-K
Item: Item 1A
Chunk 33
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 attain profitability, or commercialize products
for which we may receive regulatory approval.

40

We
plan to conduct clinical trials at sites outside the United States. The FDA may not accept data from trials conducted in such locations,
and the conduct of trials outside the United States could subject us to additional delays and expense.

We
plan to conduct one or more clinical trials with one or more trial sites that are located outside the United States. The acceptance by
the FDA or other regulatory authorities of study data from clinical trials conducted outside their jurisdiction may be subject to certain
conditions or may not be accepted at all. In cases where data from foreign clinical trials are intended to serve as the sole basis for
marketing approval in the United States, the FDA will generally not approve the application on the basis of foreign data alone unless
(i) the data are applicable to the United States population and United States medical practice; (ii) the trials were performed by clinical
investigators of recognized competence and pursuant to GCP regulations and (iii) the data may be considered valid without the need for
an on-site inspection by the FDA, or if the FDA considers such inspection to be necessary, the FDA is able to validate the data through
an on-site inspection or other appropriate means.

In
addition, even where the foreign study 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 foreign regulatory authorities
have similar approval requirements. In addition, such foreign trials would be subject to the applicable local laws of the foreign jurisdictions
where the trials are conducted. There can be no assurance that the FDA or any comparable foreign regulatory authority will accept data
from trials conducted outside of the United States or the applicable jurisdiction. If the FDA or any comparable foreign regulatory authority
does not accept such data, it would result in the need for additional trials, which could be costly and time-consuming, and which may
result in current or future product candidates that we may develop not receiving approval for commercialization in the applicable jurisdiction.

Conducting
clinical trials outside the United States also exposes us to additional risks, including risks associated with:

●
additional foreign regulatory requirements;

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foreign exchange fluctuations;

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compliance with foreign manufacturing, customs, shipment and storage requirements;

●
cultural differences