Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 62

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 62
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in our industry, and we may be unable to continue to attract and retain the qualified personnel necessary, particularly since our headquarters location is not near the primary centers
of biopharmaceutical employment, for the development of our
business. The loss of key employees or consultants or the failure to recruit or engage new employees and consultants could have a material
adverse effect on our business. In addition, any staffing interruptions resulting from geopolitical actions, including war and terrorism,
adverse public health developments, or natural disasters including earthquakes, typhoons, floods and fires, could have a material adverse
effect on our business.

Risks Related to Product Development, Regulatory
Approval, Manufacturing and Commercialization 

If we seek FDA approval to market and sell
any of our drug candidates we may be unable to demonstrate the necessary safety and efficacy to obtain such FDA approval.

In recent years, we have sought,
and in the future, we, alone or with project partners, intend to seek, FDA regulatory approval to market and sell one or more of our
assets as an FDA-approved drug. Obtaining FDA approval to market and sell pharmaceutical products is costly, time-consuming, uncertain
and subject to unanticipated delays. The FDA or other regulatory agencies may not approve a drug candidate on a timely basis or at all.
Before we obtain FDA approval for the sale of any potential drug candidates, we will be required to demonstrate through pre-clinical
studies and clinical trials that it is safe and effective for each intended use, which we may not be able to do. A failure to demonstrate
safety and efficacy of a drug candidate to the FDA’s satisfaction would result in our failure to obtain FDA approval. Moreover,
even if the FDA were to grant regulatory approval of a drug candidate, the approval may be limited to specific therapeutic areas or limited
as to its distribution, which could reduce revenue potential, and we will be subject to extensive and costly post-approval requirements
and oversight with respect to commercialization of the drug candidate.

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Even if we receive regulatory approval for
any of our drug candidates, we may not be able to successfully commercialize the product and the revenue that we generate from its sales,
if any, may be limited. 

If approved for marketing, the
commercial success of our drug candidates will depend upon each product’s acceptance by the medical community, including physicians,
patients and health care payors. The degree of market acceptance for any of our drug candidates will depend on a number of factors, including:

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