Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 243

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 243
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 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 approval contingent on the performance of costly post-marketing clinical trials, or may approve any
of our drug candidates with a label that does not include the labeling claims necessary or desirable for the successful commercialization
of that indication. Further, the FDA or comparable foreign regulatory authorities may place conditions on approvals or require risk management
plans or a Risk Evaluation and Mitigation Strategy (“REMS”) to assure the safe use of the drug. If the FDA concludes a REMS
is needed, the sponsor of the NDA must submit a proposed REMS; the FDA will not approve the NDA without an approved REMS, if required.
A REMS could include medication guides