Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 257

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 257
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 clinical sites will devote to our program or any of our drug candidates. If we are unable to rely on clinical data collected
by our CROs, we could be required to repeat, extend the duration of, or increase the size of our clinical trials, which could significantly
delay commercialization and require significantly greater expenditures.

If any of our relationships with
these third-party CROs or clinical sites terminate, we may not be able to enter into arrangements with alternative CROs or clinical sites.
If CROs do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced
or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols,
regulatory requirements or for other reasons, any such clinical trials may be extended, delayed or terminated, and we may not be able
to obtain regulatory approval for or successfully commercialize our drug candidates. As a result, our financial results and the commercial
prospects for any of our drug candidates would be harmed, our costs could increase and our ability to generate revenue could be delayed.

Any termination or suspension of, or delays
in the commencement or completion of, any necessary studies of any of our drug candidates for any indications could result in increased
costs to us, delay or limit our ability to generate revenue and adversely affect our commercial prospects. 

The commencement and completion
of clinical studies can be delayed for a number of reasons, including delays related to:

    ●
    the FDA or a comparable foreign regulatory authority failing to grant
    permission to proceed and placing the clinical study on hold; 

    ●
    subjects for clinical testing failing to enroll or remain in our trials
    at the rate we expect;

    ●
    a facility manufacturing any of our drug candidates being ordered by
    the FDA or other government or regulatory authorities to temporarily or permanently shut down due to violations of cGMP requirements
    or other applicable requirements, or cross-contaminations of drug candidates in the manufacturing process; 

    ●
    any changes to our manufacturing process that may be necessary or desired;

    ●
    subjects choosing an alternative treatment for the indications for
    which we are developing our drug candidates, or participating in competing clinical studies; 

    ●
    subjects experiencing severe or unexpected drug-related adverse effects;

    ●
    reports from clinical testing on similar technologies and products
    raising safety and/or efficacy concerns; 

    ●
    third-party clinical investigators