Company: LBRX
Filing Date: 2025-07-23
Form Type: DRS/A
Source: 0000950123-25-006557
Chunk: 218

Company: LB PHARMACEUTICALS INC
Filing Date: 2025-07-23
Form: DRS/A
Chunk 218
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. Drug Development Process In the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act of 1938, or the FDCA, and its implementing regulations. A new drug must be approved by the FDA through the NDA process before it may be legally marketed in the United States. Failure to comply with the applicable U.S. requirements at any time during the product development or approval process, or after approval, may subject an applicant to administrative or judicial sanctions brought by the FDA and the Department of Justice, or DOJ, or other governmental entities. The process required by the FDA before a drug may be marketed in the United States generally involves the following:

| • |     | completion of preclinical laboratory tests, animal studies and formulation studies in accordance with FDA’s 
 GLP regulations and other applicable requirements;                                                          |

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

| • |     | approval by an IRB or ethics committee before each clinical trial may be initiated; |

| • |     | performance of adequate and well-controlled human clinical trials in accordance with GCPs to evaluate the safety 
 and efficacy of the proposed drug for its intended use;                                                          |

| • |     | preparation of and submission to the FDA of an NDA; |

| • |     | a determination by the FDA within 60 days of its receipt of an NDA to file the application for review; |

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

| • |     | satisfactory completion of FDA inspections of the manufacturing facility or facilities at which the drug is                                                                                                                                      
 produced to assess readiness for commercial manufacturing and conformance to the manufacturing-related elements of the application, to conduct a data integrity audit, and to assess compliance with current cGMP regulations to assure that the 
 facilities, methods and controls are adequate to preserve the drug’s identity, strength, quality and purity, and a potential inspection of selected clinical investigation sites to assess compliance with GCPs; and                             |

| • |     | FDA review and approval of the NDA. |

Preclinical Studies and IND Application Once a product candidate is identified for development, it enters the preclinical development stage. The preclinical developmental stage generally involves laboratory evaluations of chemistry, formulation, and stability, as well as studies to evaluate the product candidate’s toxicity, in an effort to support subsequent clinical testing. Such toxicity studies generally involve the use of animals, althoughan N