Company: MIRA
Filing Date: 2025-08-08
Form Type: DEFM14A
Source: 0001641172-25-022816
Chunk: 83

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-08-08
Form: DEFM14A
Chunk 83
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 development and FDA-process than SKNY-1 or have more resources than SKNY. These companies include:

| - | Pfizer                                                                                           
 Inc. (NYSE: PFE) - PFE is developing Chantix (Varenicline), a prescription medication used       
 to help adults quit smoking. It works by binding to nicotine receptors in the brain, reducing    
 both cravings and withdrawal symptoms while also blocking the pleasurable effects of nicotine    
 if a person smokes.                                                                              |
| - | GlaxoSmithKline                                                                                  
 (NYSE: GSK) – GSK is developing Zyban (Bupropion), a prescription medication                     
 used to help people quit smoking. Bupropion, an antidepressant also marketed as Zyban for        
 smoking cessation, reduces weight gain by approximately 1.01 kg at the end of treatment compared 
 to placebo. It is an atypical antidepressant that works by reducing nicotine cravings and        
 withdrawal symptoms. Zyban influences dopamine and norepinephrine, neurotransmitters involved    
 in addiction and mood regulation.                                                                |

| 44 |

Regulation

The FDA and comparable regulatory authorities in state and local jurisdictions impose substantial and burdensome requirements upon companies involved in the clinical development, manufacture, marketing, and distribution of drugs. These agencies and other federal, state, and local entities regulate, among other things, the research and development, testing, manufacture, quality control, safety, effectiveness, labeling, storage, record keeping, approval, advertising and promotion, distribution, post-approval monitoring and reporting, sampling and export and import of our drug candidates.

U.S. Government Regulation

In the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act, or FDCA, and its implementing regulations. The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local and foreign statutes and regulations requires the expenditure of substantial time and financial resources. Failure to comply with the applicable U.S. requirements at any time during the product development process, approval process or after approval, may subject an applicant to a variety of administrative or judicial sanctions, such as the FDA’s refusal to approve pending New Drug Applications (or NDAs), withdrawal of an approval, imposition of a clinical hold, issuance of warning letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement or civil or criminal penalties. The process required by the FDA before a drug may be marketed in the