Company: ARTL
Filing Date: 2025-05-13
Form Type: 10-Q
Source: 0001640334-25-000825
Chunk: 321

Company: ARTELO BIOSCIENCES, INC.
Filing Date: 2025-05-13
Form: 10-Q
Item: Part I, Item 4
Chunk 321
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 or feedback on clinical trial design, to commence a clinical trial; ·identify, recruit and train suitable clinical investigators; ·reach agreement on acceptable terms with prospective CROs and clinical trial sites; ·obtain and maintain IRB, approval at each clinical trial site; ·identify, recruit, and enroll suitable patients to participate in a clinical trial; ·have a sufficient number of patients complete a clinical trial or return for post-treatment follow-up; ·ensure clinical investigators observe clinical trial protocol or continue to participate in a clinical trial; ·address any patient safety concerns that arise during the course of a clinical trial; ·address any conflicts with new or existing laws or regulations; ·add a sufficient number of clinical trial sites; ·timely manufacture sufficient quantities of a product candidate for use in clinical trials; or ·raise sufficient capital to fund a clinical trial.

Patient enrollment is a significant factor in the timing of clinical trials and is affected by many factors, including the size and nature of the patient population, the proximity of patients to clinical sites, the eligibility criteria for the clinical trial, the design of the clinical trial, competing clinical trials and clinicians’ and patients’ or caregivers’ perceptions as to the potential advantages of the drug candidate being studied in relation to other available therapies, including any new drugs or treatments that may be approved for the indications we are investigating.

We could also encounter delays if a clinical trial is suspended or terminated by us, by the data safety monitoring board for such clinical trial or by the FDA or any other regulatory authority, or if the IRBs of the institutions in which such clinical trials are being conducted suspend or terminate the participation of their clinical investigators and sites subject to their review. Such authorities may suspend or terminate a clinical trial due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements, including GCPs or the approved clinical protocols, inspection of the clinical trial operations or clinical trial site by the FDA or other regulatory authorities resulting in a finding of non-compliance, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a product candidate, changes in governmental regulations or administrative actions, or lack of adequate funding to continue the clinical trial.

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If we experience delays in the completion of, or termination of, any clinical trial of our product candidates for any reason, the commercial prospects of our product candidates may be harmed, and our ability to generate product revenues from any of these product candidates will