Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 249

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 249
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 a small percentage result in the submission of an NDA to the FDA and even fewer are eventually approved for commercialization. If
our development efforts for our drug candidates, including regulatory approval, are not successful for their planned indications, or
if adequate demand for our drug candidates is not generated, our business will be materially adversely affected.

Our success depends on the receipt
of regulatory approval and the issuance of such regulatory approvals is uncertain and subject to a number of risks, including the following:

    ●
    the results of toxicology studies may not support the filing of an
    investigational new drug application for our drug candidates;

    ●
    the FDA or comparable foreign regulatory authorities or Institutional
    Review Boards (“IRBs”) may disagree with the design or implementation of our clinical trials;

    ●
    we may not be able to provide acceptable evidence of our drug candidates’
    safety and efficacy;

 41 

    ●
    the results of our clinical trials may not be satisfactory or may not
    meet the level of statistical or clinical significance required by the FDA, the European Medicines Agency (the “EMA”),
    or other regulatory agencies for marketing approval;

    ●
    the dosing of our drug candidates in a particular clinical trial may
    not be at an optimal level;

    ●
    patients in our clinical trials may suffer adverse effects for reasons
    that may or may not be related to our drug candidates;

    ●
    the data collected from clinical trials may not be sufficient to support
    the submission of an NDA, BLA or other submission or to obtain regulatory approval in the U.S. or elsewhere;

    ●
    the FDA or comparable foreign regulatory authorities may fail to approve
    the manufacturing processes or facilities of third-party manufacturers with which we contract for clinical and commercial supplies;
    and

    ●
    the approval policies or regulations of the FDA or comparable foreign
    regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.

Failure to obtain regulatory
approval for our drug candidates for the foregoing, or any other reasons, will prevent us from commercializing our drug candidates, and
our ability to generate revenue will be materially impaired. We cannot guarantee that regulators will agree with our assessment of the
results of the clinical trials we intend to conduct in the future or that such trials will be successful. The FDA, EMA and other regulators
have substantial discretion in the approval process and may refuse to accept any application or may decide that our