Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 250

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 250
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 data is insufficient
for approval and require additional clinical trials, or pre-clinical or other studies. In addition, varying interpretations of the data
obtained from pre-clinical and clinical testing could delay, limit or prevent regulatory approval of our drug candidates.

Excluding any activities through
our ownership interest in Eton, we have not received regulatory approval to market our drug candidates in any jurisdiction. We have only
limited experience in filing the applications necessary to gain regulatory approvals and expect to rely on consultants and CROs, with
expertise in this area to assist us in this process. Securing regulatory approvals to market a product requires the submission of pre-clinical,
clinical, and/or pharmacokinetic data, information about product manufacturing processes and inspection of facilities and supporting
information to the appropriate regulatory authorities for each therapeutic indication to establish a drug candidate’s safety and
efficacy for each indication. Our drug candidates may prove to have undesirable or unintended side effects, toxicities or other characteristics
that may preclude us from obtaining regulatory approval or prevent or limit commercial use with respect to one or all intended indications.

The process of obtaining regulatory
approvals is expensive, often takes many years, if approval is obtained at all, and can vary substantially based upon, among other things,
the type, complexity and novelty of the drug candidates involved, the jurisdiction in which regulatory approval is sought and the substantial
discretion of the regulatory authorities. Changes in regulatory approval policies during the development period, changes in or the enactment
of additional statutes or regulations, or changes in regulatory review for a submitted product application may cause delays in the approval
or rejection of an application. Regulatory approval obtained in one jurisdiction does not necessarily mean that a drug candidate will
receive regulatory approval in all jurisdictions in which we may seek approval, but the failure to obtain approval in one jurisdiction
may negatively impact our ability to seek approval in a different jurisdiction. Failure to obtain regulatory marketing approval for our
drug candidates in any indication will prevent us from commercializing the drug candidate, and our ability to generate revenue will be
materially impaired.

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Obtaining and maintaining regulatory approval
of our products and drug candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of
our products or drug candidates in other jurisdictions.

Obtaining and maintaining regulatory
approval of our drug candidates in one jurisdiction does not guarantee that we will be able to obtain or maintain regulatory approval
in any other jurisdiction, but a failure or delay