Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 63

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 63
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    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 show utility;

    ●
    pricing and cost-effectiveness;

    ●
    the inclusion or omission of our drug candidates in applicable therapeutic
    and vaccine guidelines;

    ●
    the effectiveness of our own or any future collaborators’ sales
    and marketing strategies;

    ●
    limitations or warnings contained in approved labeling from regulatory
    authorities;

    ●
    our ability to obtain and maintain sufficient third-party coverage
    or reimbursement from government health care programs, including Medicare and Medicaid, private health insurers and other third-party
    payors or to receive the necessary pricing approvals from government bodies regulating the pricing and usage of therapeutics; and

    ●
    the willingness of patients to pay out-of-pocket in the absence of
    third-party coverage or reimbursement or government pricing approvals.

If any of our drug candidates
are approved, but do not achieve an adequate level of acceptance by physicians, health care payors, and patients, we may not generate
sufficient revenue and we may not be able to achieve or sustain profitability. Our efforts to educate the medical community and third-party
payors on the benefits of our drug candidates may require significant resources and may never be successful.

In addition, even if we obtain
regulatory approvals, the timing or scope of any approvals may prohibit or reduce our ability to commercialize our drug candidates successfully.
For example, if the approval process takes too long, we may miss market opportunities and give other companies the ability to develop
competing products or establish market dominance. Any regulatory approval we ultimately obtain may be limited or subject to restrictions
or post-approval commitments that render our drug candidates not commercially viable. For example, regulatory authorities may approve
any of our drug candidates for fewer or more limited indications than we request, may not approve the price we intend to charge for any
of our drug candidates, may grant