Company: SMNR
Filing Date: 2025-04-21
Form Type: CORRESP
Source: 0001193125-25-087365
Chunk: 14

Company: Semnur Pharmaceuticals, Inc.
Filing Date: 2025-04-21
Form: CORRESP
Chunk 14
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 the                                   |

12

U.S. Securities and Exchange Commission April 21, 2025

| NDA. Please revise to discuss in greater detail the disagreement with FDA, including the availability of the 505(b)(2) pathway, the guidance you received, and when you received it. In this                                            
 regard, we note Scilex’s November 2, 2023 press release announced a Positive Type C Meeting with FDA and discussed Scilex’s plan to commence an open-label multi-center safety and efficacy trial in the first half of 2024 in which it 
 would seek to enroll approximately 700 patients with moderate-to-severe Lumbosacral Radicular Pain (LRP).                                                                                                                               |

Response: The Company respectfully advises the Staff that it has revised the disclosure on pages 85, 112 and 288 of Amendment No. 1 in response to the Staff’s comment. Our Strategy, page 263

| 30. | In the last paragraph on page 263, you state that you expect efficacy of                                                                                                                                                                                
 SP-102 to last up to approximately 100 days and that you expect SP-102 to have proven safety based on data from your preclinical and clinical trials. Please revise the                                                                                 
 disclosure, and any similar disclosures located elsewhere in the prospectus, so that you are not stating or implying that the product candidate is safe or effective, or that it will be determined to be safe or effective, as such determinations are 
 solely within the authority of the FDA.                                                                                                                                                                                                                 |

Response: The Company respectfully advises the Staff that it has revised the disclosure on pages 35, 287, 289, 293, 294, 295, 299, 300, 304, 307, 326 and 327 of Amendment No. 1 in response to the Staff’s comment.

| 31. | In the third bullet point on page 264, you state that a principal element of your strategy is to leverage                                                                                                                                              
 the robust and integrated commercial infrastructure and other functions of your parent company, Scilex, to commercialize your current and future product candidates, if approved. Please revise your disclosure to clarify the potential impact of the 
 Business Combination on this aspect of your strategy, particularly after the conclusion of any transition period. In this regard, we note your disclosure on page 298 that, in connection with the Business Combination, you intend to enter into a    
 transition services agreement with Scilex that would be in place for two years. Please make