Company: MIRA
Filing Date: 2025-07-29
Form Type: PRER14A
Source: 0001641172-25-021434
Chunk: 86

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-07-29
Form: PRER14A
Chunk 86
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:

| ● | Phase                                                                                               
 I clinical trials generally involve a small number of healthy volunteers or disease-affected        
 patients who are initially exposed to a single dose and then multiple doses of the product          
 candidate. The primary purpose of these clinical trials is to assess the metabolism, pharmacologic  
 action, side effect tolerability and safety of the drug.                                            |
| ● | Phase                                                                                               
 II clinical trials involve studies in disease-affected patients to determine the dose required      
 to produce the desired benefits. At the same time, safety and further pharmacokinetic and           
 pharmacodynamic information is collected, possible adverse effects and safety risks are identified, 
 and a preliminary evaluation of efficacy is conducted.                                              |

| 46 |

| ● | Phase                                                                                       
 III clinical trials generally involve a larger number of patients at multiple sites and are 
 designed to provide the data necessary to demonstrate the effectiveness of the product for  
 its intended use, its safety in use and to establish the overall benefit/risk relationship  
 of the product and provide an adequate basis for product approval. These trials may include 
 comparisons with placebo and/or other comparator treatments. The duration of treatment is   
 often extended to mimic the actual use of a product during marketing.                       |

Post-approval trials, sometimes referred to as Phase IV clinical trials, may be conducted after initial marketing approval. These trials are used to gain additional experience from the treatment of patients in the intended therapeutic indication, particularly for long-term safety follow up. In certain instances, the FDA may mandate the performance of Phase IV clinical trials as a condition of approval of an NDA or a Biologics License Application (“BLA”).

Progress reports detailing the results of the clinical trials must be submitted at least annually to the FDA and more frequently if significant adverse events (“SAEs”) occur. The FDA or the sponsor may suspend or terminate a clinical trial at any time, or the FDA may impose other sanctions on various grounds, including a finding that the research patients are being exposed to an unacceptable health risk. Similarly, an IRB can refuse, suspend, or terminate approval of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the drug has been associated with unexpected serious harm to patients.

Concurrently with clinical trials, companies usually complete additional pre-clinical studies and must also develop additional information about the physical characteristics of the drug or biological product as well as finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements. The manufacturing process must be