Company: SMNR
Filing Date: 2025-08-12
Form Type: S-4/A
Source: 0001193125-25-178821
Chunk: 519

Company: Semnur Pharmaceuticals, Inc.
Filing Date: 2025-08-12
Form: S-4/A
Chunk 519
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 States generally involves the following:

| • |     | completion of preclinical laboratory tests, animal studies and formulation studies according to GLPs or other applicable regulations; |

| • |     | completion of FDA’s drug substance (Part 210), drug product (Part 211), combination of product and device (Part 820) and all Module 3, CMC, and cGMP requirements for NDA filing; |

| • |     | submission to the FDA of an Investigational New Drug Application (“IND”), which must become effective before human clinical trials may begin; |

| • |     | approval by an IRB covering each clinical site before each trial may be initiated; |

| • |     | performance of adequate and well-controlled human clinical trials according to the laws and regulations pertaining to the conduct of human clinical trials, collectively referred to as GCP requirements to establish the safety and efficacy of the proposed drug product for its intended use; |

| • |     | submission to the FDA of an NDA or other marketing application, for a proposed new drug product, including its specific formulation and labeling; |

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

| • |     | satisfactory completion of an FDA pre-approval inspection (PAI) of the manufacturing facility or facilities where the drug substance, drug product, packaging components and device are produced to assess compliance with the FDA’s cGMP requirements to assure that the facilities, manufacturing, methods and controls are adequate to preserve the drug product’s identity, strength, quality and purity; |

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| • |     | potential FDA audit of the preclinical study and clinical trial sites that generated the data in support of the NDA; and |

| • |     | FDA review and approval of the NDA prior to any commercial marketing, sale, distribution or shipment of the drug product. |

Before testing novel compounds with potential therapeutic value in humans, the drug candidate enters the preclinical testing stage, also referred to as preclinical studies. Preclinical studies include laboratory evaluations of product chemistry, toxicity and formulation, as well as animal studies to assess the potential safety and activity of the drug product candidate. The conduct of the preclinical studies must comply with federal laws and requirements including GLPs. The IND sponsor must submit the results of the preclinical studies, together with manufacturing information, analytical data, and any available clinical data or literature, to the FDA as part of the IND. The sponsor will also include a protocol detailing, among other things,