Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 242

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 242
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Approval, Manufacturing and Commercialization 

If we seek FDA approval to market and sell
any of our drug candidates we may be unable to demonstrate the necessary safety and efficacy to obtain such FDA approval.

In recent years, we have sought,
and in the future, we, alone or with project partners, intend to seek, FDA regulatory approval to market and sell one or more of our
assets as an FDA-approved drug. Obtaining FDA approval to market and sell pharmaceutical products is costly, time-consuming, uncertain
and subject to unanticipated delays. The FDA or other regulatory agencies may not approve a drug candidate on a timely basis or at all.
Before we obtain FDA approval for the sale of any potential drug candidates, we will be required to demonstrate through pre-clinical
studies and clinical trials that it is safe and effective for each intended use, which we may not be able to do. A failure to demonstrate
safety and efficacy of a drug candidate to the FDA’s satisfaction would result in our failure to obtain FDA approval. Moreover,
even if the FDA were to grant regulatory approval of a drug candidate, the approval may be limited to specific therapeutic areas or limited
as to its distribution, which could reduce revenue potential, and we will be subject to extensive and costly post-approval requirements
and oversight with respect to commercialization of the drug candidate.

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Even if we receive regulatory approval for
any of our drug candidates, we may not be able to successfully commercialize the product and the revenue that we generate from its sales,
if any, may be limited. 

If approved for marketing, the
commercial success of our drug candidates will depend upon each product’s acceptance by the medical community, including physicians,
patients and health care payors. The degree of market acceptance for any of our drug candidates will depend on a number of factors, including:

    ●
    demonstration of clinical safety and efficacy;

    ●
    relative convenience, dosing burden and ease of administration;

    ●
    the prevalence and severity of any adverse effects;

    ●
    the willingness of physicians to prescribe our drug candidates, and
    the target patient population to try new therapies;

    ●
    efficacy of our drug candidates compared to competing products;

    ●
    the introduction of any new products that may in the future become
    available targeting indications for which our drug candidates may be approved;

    ●
    new procedures or therapies that may reduce the incidences of any of
    the indications in which our drug candidates may