Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 79

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 79
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 termination of a trial. 

Product development costs for
any of our drug candidates will increase if we have delays in testing or approval or if we need to perform more or larger clinical studies
than planned. Additionally, changes in regulatory requirements and policies may occur and we may need to amend study protocols to reflect
these changes. Amendments may require us to resubmit our study protocols to the FDA, comparable foreign regulatory authorities, and IRBs
for reexamination, which may impact the costs, timing or successful completion of that study. If we experience delays in completion of,
or if we, the FDA or other regulatory authorities, the IRB, or other reviewing entities, or any of our clinical study sites suspend or
terminate any of our clinical studies of any of our drug candidates, its commercial prospects may be materially harmed and our ability
to generate product revenues will be delayed. Any delays in completing our clinical trials will increase our costs, slow down our development
and approval process and jeopardize our ability to commence product sales and generate revenues. Any of these occurrences may harm our
business, financial condition and prospects significantly. In addition, many of the factors that cause, or lead to, termination or suspension
of, or a delay in the commencement or completion of, clinical studies may also ultimately lead to the denial of regulatory approval of
our drug candidates. In addition, if one or more clinical studies are delayed, our competitors may be able to bring products to market
before we do, and the commercial viability of any of our drug candidates could be significantly reduced.

Even though we may apply for orphan drug designation
for a drug candidate, we may not be able to obtain orphan drug marketing exclusivity.

There is no guarantee that the
FDA, EMA or their foreign equivalents will grant any future application for orphan drug designation for any of our drug candidates, which
would make us ineligible for the additional exclusivity and other benefits of orphan drug designation.

Under the Orphan Drug Act, the
FDA may grant orphan drug designation to a drug intended to treat a rare disease or condition, which is generally a disease or condition
that affects fewer than 200,000 individuals in the U.S. and for which there is no reasonable expectation that the cost of developing
and making a drug available in the Unites States for this type of disease or condition will be recovered from sales of the product. Orphan
drug designation must be requested before submitting an NDA. After the FDA grants orphan drug designation, the identity of the therapeutic