Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 248

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 248
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 most drug candidates
never reach the clinical development stage and even those that do commence clinical development have only a small chance of successfully
completing clinical development and gaining regulatory approval. Therefore, aspects of our business depend on the successful development,
regulatory approval and commercialization of our drug candidates, which may never occur.

If we are not able to obtain required regulatory
approvals for a drug candidate, we will not be able to commercialize such drug candidate and our ability to generate revenues will be
limited. 

We must successfully complete
clinical trials for our drug candidates before we can apply for marketing approval. Even if we complete our clinical trials, it does
not assure marketing approval. Our clinical trials may be unsuccessful, which would materially harm our business. Even if our initial
clinical trials are successful, we are required to conduct additional clinical trials to establish our drug candidates’ safety
and efficacy, before an NDA or Biologics License Application (“BLA”), or their foreign equivalents can be filed with the
FDA or comparable foreign regulatory authorities for marketing approval of our drug candidates.

Clinical testing is expensive,
is difficult to design and implement, can take many years to complete and is uncertain as to outcome. Success in early phases of pre-clinical
and clinical trials does not ensure that later clinical trials will be successful, and interim results of a clinical trial do not necessarily
predict final results. A failure of one or more of our clinical trials can occur at any stage of testing. We may experience numerous
unforeseen events during, or as a result of, the clinical trial process that could delay or prevent our ability to receive regulatory
approval or commercialize our drug candidates. The research, testing, manufacturing, labeling, packaging, storage, approval, sale, marketing,
advertising and promotion, pricing, export, import and distribution of drug products are subject to extensive regulation by the FDA and
other regulatory authorities in the U.S. and other countries, which regulations differ from country to country. We are not permitted
to market our drug candidates as prescription pharmaceutical products in the U.S. until we receive approval of an NDA from the FDA, or
in any foreign countries until we receive the requisite approval from such countries. In the U.S., the FDA generally requires the completion
of clinical trials of each drug to establish its safety and efficacy and extensive pharmaceutical development to ensure its quality before
an NDA is approved. Regulatory authorities in other jurisdictions impose similar requirements. Of the large number of drugs in development,
only