Company: MIRA
Filing Date: 2025-03-28
Form Type: 10-K
Source: 0001641172-25-001183
Chunk: 34

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-03-28
Form: 10-K
Item: Item 1A
Chunk 34
---
 in medical practice and clinical research;

●
diminished protection of intellectual property in some countries; and

●
interruptions or delays in our trials resulting from geopolitical events, such as war or terrorism.

The
regulatory approval processes with the FDA are lengthy and inherently unpredictable.

We
are not permitted to market our drug candidates as medicines in the United States or other countries until we receive approval of a New
Drug Application (“NDA”) from the FDA or in any foreign countries until we receive the approval from the regulatory authorities
of such countries. Prior to submitting an NDA to the FDA for approval of our drug candidates we will need to have completed our pre-clinical
studies and clinical trials and demonstrate that our products meet all applicable standards of identity, strength, quality, and purity
throughout their expiration date. Successfully completing any clinical program and obtaining approval of an NDA is a complex, lengthy,
expensive, and uncertain process, and the FDA (or other country medicines regulatory body) may delay, limit, or deny approval of product
candidates for many reasons, including, among others, because:

    ●
    an
    inability to demonstrate that our product candidates are safe and effective in treating patients to the satisfaction of the FDA;

41

    ●
    results
    of clinical trials that may not meet the level of statistical or clinical significance required by the FDA;

    ●
    disagreements
    with the FDA with respect to the number, design, size, conduct or implementation of clinical trials;

    ●
    requirements
    by the FDA to conduct additional clinical trials;

    ●
    disapproval
    by the FDA of certain formulations, labeling or specifications of product candidates;

    ●
    findings
    by the FDA that the data from pre-clinical studies and clinical trials are insufficient;

    ●
    findings
    by the FDA that our API or finished products do not meet all applicable standards of identity, strength, quality, and purity;

    ●
    the
    FDA may disagree with the interpretation of data from pre-clinical studies and clinical trials; and

    ●
    the
    FDA may change their approval policies or adopt new regulations.

Any
of these factors, many of which are beyond our control, could increase development time and / or costs or jeopardize our ability to obtain
regulatory approval for our drug candidates.

There
is a high rate of failure for drug candidates proceeding through clinical trials.

Generally,
there is a high