Company: MIRA
Filing Date: 2025-03-28
Form Type: 10-K
Source: 0001641172-25-001183
Chunk: 31

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-03-28
Form: 10-K
Item: Item 1A
Chunk 31
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 we, and our contract manufacturers (in the event contract manufacturers are appointed
in the future) are subject to continual review and periodic inspections to assess compliance with GMP. Accordingly, we and others with
whom we work must continue to spend time, money, and effort in all areas of regulatory compliance, including manufacturing, production,
quality control and quality assurance. We will also be required to report certain adverse reactions and production problems, if any,
to the FDA, and to comply with requirements concerning advertising and promotion for our products. Promotional communications with respect
to prescription drugs are subject to a variety of legal and regulatory restrictions and must be consistent with the information in the
product’s approved label.

39

If
a regulatory agency discovers previously unknown problems with a product, such as adverse events of unanticipated severity or frequency,
or problems with the facility where the product is manufactured, or disagrees with the promotion, marketing or labeling of the product,
it may impose restrictions on that product or us, including requiring withdrawal of the product from the market. If we fail to comply
with applicable regulatory requirements, a regulatory agency or enforcement authority may:

    ●
    issue
    untitled or warning letters;

    ●
    seek
    to enjoin our activities;

    ●
    impose
    civil or criminal penalties;

    ●
    suspend
    regulatory approval;

    ●
    suspend
    any of our ongoing clinical trials;

    ●
    refuse
    to approve pending applications or supplements to approved applications submitted by us;

    ●
    impose
    restrictions on our operations, including by requiring us to enter into a Corporate Integrity Agreement or closing our contract manufacturers’
    facilities, if any; or

    ●
    seize
    or detain products or require a product recall.

In
addition, any government investigation of alleged violations of law could require us to expend significant time and resources in response
and could generate negative publicity. Any failure to comply with ongoing regulatory requirements may significantly and adversely affect
our ability to commercialize and generate revenue from our product candidates. If regulatory sanctions are applied or if regulatory approval
is withdrawn, the value of our business and our operating results may be adversely affected.

Any
action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses,
divert our management’s attention from the operation of our business and damage our reputation. We expend significant resources
on compliance efforts and such expenses are unpredictable and might adversely