Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 260

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 260
---
, which means the FDA may not approve any other applications to market the same drug for the same
indication for seven years, except in limited circumstances, such as (i) the drug’s orphan designation is revoked; (ii) its marketing
approval is withdrawn; (iii) the orphan exclusivity holder consents to the approval of another applicant’s product; (iv) the orphan
exclusivity holder is unable to assure the availability of a sufficient quantity of drug; or (v) a showing of clinical superiority to
the product with orphan exclusivity by a competitor product. If a drug designated as an orphan product receives marketing approval for
an indication broader than what is designated, it may not be entitled to orphan drug exclusivity. There can be no assurance that we will
receive orphan drug designation for any of our drug candidates in the indications for which we think they might qualify, if we elect
to seek such applications.

Although we may pursue expedited regulatory
approval pathways for a drug candidate, it may not qualify for expedited development or, if it does qualify for expedited development,
it may not actually lead to a faster development or regulatory review or approval process.

Although we believe there may
be an opportunity to accelerate the development of certain of our drug candidates through one or more of the FDA’s expedited programs,
such as fast track, breakthrough therapy, accelerated approval or priority review, we cannot be assured that any of our drug candidates
will qualify for such programs.

For example, a drug may be eligible
for designation as a breakthrough therapy if the drug is intended, alone or in combination with one or more other drugs, to treat a serious
or life-threatening condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over
existing therapies on one or more clinically significant endpoints. Although breakthrough designation or access to any other expedited
program may expedite the development or approval process, it does not change the standards for approval. If we apply for breakthrough
therapy designation or any other expedited program for our drug candidates, the FDA may determine that our proposed target indication
or other aspects of our clinical development plans do not qualify for such expedited program. Even if we are successful in obtaining
a breakthrough therapy designation or access to any other expedited program, we may not experience faster development timelines or achieve
faster review or approval compared to conventional FDA procedures. Access to an expedited program may also be withdrawn by the FDA if
it believes that the designation is no longer supported by data from our