Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 69

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 69
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 to extensive regulation by the FDA and
other regulatory authorities in the U.S. and other countries, which regulations differ from country to country. We are not permitted
to market our drug candidates as prescription pharmaceutical products in the U.S. until we receive approval of an NDA from the FDA, or
in any foreign countries until we receive the requisite approval from such countries. In the U.S., the FDA generally requires the completion
of clinical trials of each drug to establish its safety and efficacy and extensive pharmaceutical development to ensure its quality before
an NDA is approved. Regulatory authorities in other jurisdictions impose similar requirements. Of the large number of drugs in development,
only 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;

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    ●
    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