Company: TELO
Filing Date: 2025-02-14
Form Type: S-3
Source: 0001493152-25-006943
Chunk: 37

Company: Telomir Pharmaceuticals, Inc.
Filing Date: 2025-02-14
Form: S-3
Chunk 37
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 be approved in the U.S. in the future, will be subject to ongoing regulatory requirements for manufacturing, labeling, packaging, storage, distribution, import, export, advertising, promotion, sampling, recordkeeping and submission of safety and other post-market information, including both federal and state requirements in the U.S. In addition, manufacturers and manufacturers’ facilities are required to comply with extensive FDA requirements, including ensuring that quality control and manufacturing procedures conform to GMP. As such, 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.

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; |

| Alt-7 |

| ● | 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