Company: CRVO
Filing Date: 2025-03-17
Form Type: 10-K
Source: 0001437749-25-007829
Chunk: 51

Company: CervoMed Inc.
Filing Date: 2025-03-17
Form: 10-K
Item: Item 1A
Chunk 51
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 data from open-label uncontrolled studies, which are generally not capable of providing interpretable evidence of efficacy. There can be no assurance that future large, well-controlled, multi-dose studies will demonstrate the safety, tolerability or efficacy of neflamapimod to treat patients with any indication, including DLB.

Even if our clinical trials for neflamapimod are completed as planned, we cannot be certain that their results will support the substantial evidence of safety and efficacy needed to obtain regulatory approval. The failure of neflamapimod to show safety, tolerability or efficacy in any future clinical studies would significantly harm the Company's business.

Enrollment and retention of participants in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside the Company’s control.

The timely completion of clinical trials in accordance with their protocols depends on, among other things, the Company’s ability to enroll a sufficient number of research participants who remain in the study until its conclusion. The Company may encounter delays in enrolling, or be unable to enroll, a sufficient number of individuals to complete any of its clinical trials, and even once enrolled the Company may be unable to retain a sufficient number of participants to complete any of its trials. Subject enrollment and retention in clinical trials depends on many factors, including:

  the eligibility criteria defined in the protocol;  

  the size of the patient population required for analysis of the trial’s primary endpoints;  

  the nature of the trial protocol;  

  the proximity of potential subjects to clinical sites;  

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  the existing body of safety and efficacy data with respect to the product candidate;  

  the Company’s ability to recruit clinical trial investigators with the appropriate competencies and experience;  

  clinicians’ and patients’ perceptions as to the potential advantages of the product candidate being studied in relation to other available therapies;  

  competing clinical trials being conducted by other companies or institutions;  

  the risk that participants enrolled in clinical trials will drop out of the trials before completion; and  

  the operational efficiency of trial sites, including sufficient staffing.  

In addition, the U. S. Congress recently amended the FDCA to require sponsors of a Phase 3 clinical trial or other “pivotal study” of a new drug or biologic to support MA, to design and submit a diversity action plan for such clinical trial. The action plan must describe appropriate diversity goals for enrollment, as well as a rationale for the goals and a description of how the sponsor will meet them.