Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 258

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 258
---
 losing their license or permits
    necessary to perform our clinical trials, not performing our clinical trials on our anticipated schedule or employing methods consistent
    with the clinical trial protocol, cGMP requirements, or other third parties not performing data collection and analysis in a timely
    or accurate manner; 

    ●
    inspections of clinical study sites by the FDA, comparable foreign
    regulatory authorities, or IRBs finding regulatory violations that require us to undertake corrective action, result in suspension
    or termination of one or more sites or the imposition of a clinical hold on the entire study, or that prohibit us from using some
    or all of the data in support of our marketing applications; 

 46 

    ●
    third-party contractors becoming debarred or suspended or otherwise
    penalized by the FDA or other government or regulatory authorities for violations of regulatory requirements, in which case we may
    need to find a substitute contractor, and we may not be able to use some or any of the data produced by such contractors in support
    of our marketing applications; 

    ●
    one or more IRBs refusing to approve, suspending or terminating the
    study at an investigational site, precluding enrollment of additional subjects, or withdrawing its approval of the trial; reaching
    agreement on acceptable terms with prospective CROs and clinical trial sites, the terms of which can be subject to extensive negotiation
    and may vary significantly among different CROs and trial sites; 

    ●
    deviations of the clinical sites from trial protocols or dropping out
    of a trial; 

    ●
    adding new clinical trial sites; 

    ●
    the inability of the CRO to execute any clinical trials for any reason;
    and 

    ●
    government or regulatory delays or “clinical holds” requiring
    suspension or termination of a trial. 

Product development costs for
any of our drug candidates will increase if we have delays in testing or approval or if we need to perform more or larger clinical studies
than planned. Additionally, changes in regulatory requirements and policies may occur and we may need to amend study protocols to reflect
these changes. Amendments may require us to resubmit our study protocols to the FDA, comparable foreign regulatory authorities, and IRBs
for reexamination, which may impact the costs, timing or successful completion of that study. If we experience delays in completion of,
or if we, the FDA or other regulatory authorities, the IRB, or other reviewing