Company: MIRA
Filing Date: 2025-06-17
Form Type: PREM14A
Source: 0001641172-25-015340
Chunk: 88

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-06-17
Form: PREM14A
Chunk 88
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 following:

| ● | completion                                                                                  
 of pre-clinical laboratory tests, animal studies and formulation studies in compliance with 
 the FDA’s good laboratory practice (“GLP”) regulations;                                     |

| ● | submission                                                                                 
 to the FDA of an IND application, which must become effective before human clinical trials 
 may begin;                                                                                 |

| ● | approval                                                                           
 by an independent Institutional Review Board (“IRB”), at each clinical site before 
 each trial may be initiated;                                                       |

| ● | performance                                                                                      
 of adequate and well-controlled human clinical trials in accordance with good clinical practices 
 (“GCP”) requirements to establish the safety and efficacy of the proposed drug                   
 product for each indication;                                                                     |

| ● | demonstration                                                                                    
 that the Application Programming Interface and finished product are manufactured under well      
 controlled (eventually cGMP) conditions and meet all applicable standards of identity, strength, 
 quality, and purity;                                                                             |

| ● | submission            
 to the FDA of an NDA; |

| ● | satisfactory                                                   
 completion of an FDA advisory committee review, if applicable; |

| ● | satisfactory                                                                                       
 completion of an FDA inspection of the manufacturing facility or facilities at which the           
 product is produced to assess compliance with cGMP requirements and to assure that the facilities, 
 methods, and controls are adequate to preserve the drug’s identity, strength, quality,             
 and purity;                                                                                        |

| ● | FDA                                                                                      
 review and approval of the NDA, including consideration of the views of any FDA advisory 
 committee, prior to commercial marketing or sale of the drug in the United States; and   |

| ● | compliance                                                                                   
 with any post-approval requirements, including the potential requirement to implement a Risk 
 Evaluation and Mitigation Strategy (“REMS”) or to conduct a post-approval study.             |

| 48 |

Pre-clinical studies

Before testing any drug or biological product candidate in humans, the product candidate must undergo rigorous pre-clinical testing. The pre-clinical developmental stage generally involves laboratory evaluations of drug chemistry, formulation, and stability, as well as studies to evaluate toxicity in animals, to assess the potential for adverse events (“AEs”) and, in some cases, to establish a rationale for therapeutic use. The conduct of pre-clinical studies is subject to federal regulations and requirements, including GLP regulations for safety/toxicology studies. An IND sponsor must submit the results of the pre-clinical studies, together with manufacturing information, analytical data, any available clinical data or literature and