Company: MIRA
Filing Date: 2025-03-28
Form Type: 10-K
Source: 0001641172-25-001183
Chunk: 40

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-03-28
Form: 10-K
Item: Item 1A
Chunk 40
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 and criminal liabilities for any violations of
FDA rules and regulations and the comparable foreign regulatory provisions during the conduct of our clinical trials. Outside parties
may:

    ●
    have
    staffing difficulties;

    ●
    fail
    to comply with contractual obligations;

    ●
    Devote
    inadequate resources to our clinical trials;

    ●
    Experience
    regulatory compliance issues;

    ●
    Undergo
    changes in priorities or become financially distressed; or

    ●
    Form
    more favorable relationships with other entities, some of which may be our competitors.

These
factors, among others, may materially adversely affect the willingness or ability of third parties to conduct our clinical trials and
may subject us to unexpected cost increases that are beyond our control. Nevertheless, we are responsible for ensuring that each of our
studies is conducted in accordance with the applicable protocol, legal, regulatory and scientific standards, and our reliance on CROs
does not relieve us of our regulatory responsibilities. We and our CROs are required to comply with GCPs, which are guidelines enforced
by the FDA, the competent authorities of the EU member states and equivalent competent authorities in foreign jurisdictions for any products
in clinical development. The FDA and foreign regulatory authorities enforce these regulations and GCP guidelines through periodic inspections
of clinical trial sponsors principal investigators, and trial sites, and IRBs. If we or our CROs fail to comply with applicable GCPs,
the clinical data generated in our clinical trials may be deemed unreliable and the FDA or other equivalent competent authorities in
foreign jurisdictions may require us to perform additional clinical trials before approving our marketing applications. We cannot assure
you that, upon inspection, the FDA or foreign regulatory authorities will determine that any of our clinical trials comply with GCPs.
In addition, our clinical trials must be conducted with products produced under current Good Manufacturing Practices, or cGMPs and similar
foreign requirements. Our failure or the failure of our CROs to comply with these regulations may require us to repeat clinical trials,
which would delay the regulatory approval process and could also subject us to enforcement action up to and including civil and criminal
penalties.

If
any of our relationships with these third-party CROs terminate, we may not be able to enter into arrangements with alternative CROs.
If CROs do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced
or if the quality or accuracy of the clinical