Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 67

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 67
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 injunctions or the imposition of civil or criminal penalties or monetary
    fines; 

    ●
    suspension or withdrawal of regulatory approval; 

    ●
    suspension of any ongoing clinical trials; 

    ●
    refusal to approve pending applications or supplements to approved
    applications filed by us, or suspension or revocation of product license approvals; 

    ●
    suspension or imposition of restrictions on operations, including costly
    new manufacturing requirements; or 

    ●
    product seizure or detention or refusal to permit the import or export
    of product. 

The occurrence of any event or
penalty described above may inhibit our ability to commercialize our drug candidates and generate revenue. Adverse regulatory action,
whether pre- or post-approval, can also potentially lead to product liability claims and increase our product liability exposure.

Delays in the completion of, or the termination
of, any clinical or non-clinical trials for any drug candidates for which we may seek FDA approval could adversely affect our business.

Clinical trials are very expensive,
time consuming, unpredictable and difficult to design and implement. The results of clinical trials may be unfavorable, they may continue
for several years, and they may take significantly longer to complete and involve significantly more costs than expected. Delays in the
commencement or completion of clinical testing could significantly affect product development costs and plans with respect to any drug
candidate for which we seek FDA approval. The commencement and completion of clinical trials can be delayed and experience difficulties
for a number of reasons, including delays and difficulties caused by circumstances over which we may have no control. For instance, approvals
of the scope, design or trial site may not be obtained from the FDA and other required bodies in a timely manner or at all, agreements
with acceptable terms may not be reached in a timely manner or at all with CROs to conduct the trials, a sufficient number of subjects
may not be recruited and enrolled in the trials, and third-party manufacturers of the materials for use in the trials may encounter delays
and problems in the manufacturing process, including failure to produce materials in sufficient quantities or of an acceptable quality
to complete the trials. If we were to experience delays in the commencement or completion of, or if we were to terminate, any clinical
or non-clinical trials we pursue in the future, the commercial prospects for the applicable drug candidates may be limited or eliminated,
which may prevent us from recouping our investment in research and development efforts for the drug candidate and would