Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 244

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 244
---
, physician communication plans, or elements to assure safe use, such as restricted distribution
methods, patient registries and other risk minimization tools. The FDA may also require a REMS for an approved product when new safety
information emerges. Any of these limitations on approval or marketing could restrict the commercial promotion, distribution, prescription
or dispensing of our drug candidates. Moreover, product approvals may be withdrawn for non-compliance with regulatory standards or if
problems occur following the initial marketing of the product. Any of the foregoing scenarios could materially harm the commercial success
of our drug candidates.

 38 

Clinical drug development involves a lengthy
and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results.

Clinical testing of drug candidates
is expensive and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during the clinical
trial process. The results of pre-clinical studies and early clinical trials may not be predictive of the results of later-stage clinical
trials. We cannot assure you that the FDA or comparable foreign regulatory authorities will view the results as we do or that any future
trials of any of our drug candidates will achieve positive results. Drug candidates in later stages of clinical trials may fail to show
the desired safety and efficacy traits despite having progressed through pre-clinical studies and initial clinical trials. A number of
companies in the biopharmaceutical industry have suffered significant setbacks in advanced clinical trials due to lack of efficacy or
adverse safety profiles, notwithstanding promising results in earlier trials. Any future clinical trial results for our drug candidates
may not be successful.

In addition, a number of factors
could contribute to a lack of favorable safety and efficacy results for any of our drug candidates. For example, such trials could result
in increased variability due to varying site characteristics, such as local standards of care, differences in evaluation period and surgical
technique, and due to varying patient characteristics including demographic factors and health status.

Even if we obtain marketing approval for any
of our drug candidates, we will be subject to ongoing obligations and continued regulatory review, which may result in significant additional
expense. Additionally, our drug candidates could be subject to labeling and other restrictions and withdrawal from the market and we
may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our drug
candidates. 

Even if we obtain regulatory
approval for any of our drug candidates for an indication