Company: SCLXW
Filing Date: 2025-12-29
Form Type: 424B3
Source: 0001193125-25-335429
Chunk: 309

Company: Scilex Holding Co
Filing Date: 2025-12-29
Form: 424B3
Chunk 309
---
 (Part 210), drug product (Part 211), combination of product and device            
 (Part 820) and all Module 3, Chemistry, Manufacturing and Control (“CMC”), and the 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 Good Clinical Practice (“GCP”) requirements to establish the safety and efficacy of the proposed drug for its intended use; |

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

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

| • |     | satisfactory completion of an FDA pre-approval inspection 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;                                                                                                                                                                |

| • |     | 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. |

209

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 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, the objectives of the first phase of the clinical trial, the parameters to be used in monitoring safety, and the effectiveness criteria to be evaluated, if