Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 77

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 77
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ducted at contracted clinical sites. As a result, many important aspects of our drug development programs would be outside of our
direct control. In addition, the CROs and clinical sites may not perform all of their obligations under arrangements with us or in compliance
with regulatory requirements. If the CROs or clinical sites do not perform clinical trials in a satisfactory manner, breach their obligations
to us or fail to comply with regulatory requirements, the development and commercialization of any of our drug candidates for the subject
indication may be delayed or our development program materially and irreversibly harmed. We cannot control the amount and timing of resources
these CROs and 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