Contact Us

Genelux Corporation

 

 

INVESTORS

 

For investor and journalist inquiries, please contact:
Genelux Corporation
Kim Duffy
kim.duffy@genelux.com

 

Tiberend Strategic Advisors, Inc.
Investors
Lisa Sher
lsher@tiberend.com

 

Media
Ingrid Mezo
imezo@tiberend.com

 

 

PATIENTS

 

Genelux does not recruit or select patients for clinical trials. Information about selection can be obtained from participating clinical partners or at www.clinicaltrials.gov

 

 

GENERAL INFORMATION

 

For general information, please contact:
Telephone: (858) 483-0024
Email: info@genelux.com

Expanded Access Policy

Outside of our clinical trials, we may provide physician-requested expanded access to its investigational products under limited situations. The request for access to a Genelux investigational drug will be considered only if all the following criteria are met.

 

  • The patient has a serious or life-threatening disease or condition with no comparable or satisfactory alternative therapies
  • The patient is not eligible for or unable to participate in a clinical trial
  • The investigational drug is currently in clinical development with sufficient evidence of safety and effectiveness for patient’s specific condition
  • A benefit-risk analysis suggests that the benefit from using of the investigational drug outweighs the known or anticipated risks based on evolving clinical data
  • We have adequate supply of investigational drug

 

If the investigational drug is approved by a regulatory agency for commercial use, including provisional approval, existing expanded access programs will be phased out or modified accordingly.

 

Patients interested in seeking an expanded access to a Genelux investigative drug should talk to their physician. All requests must be made by the patient’s treating physician by email at EAP@genelux.com. We will, in general, acknowledge receipt of a request for expanded access within five business days. We may ask for more detailed information to fully evaluate a request.

 

The request for access to an investigative drug can only be considered if the requesting physician agrees to obtain applicable regulatory and ethics committee approvals. We may deny access if the treating physician cannot guarantee an appropriate storage and handling of the investigative drug, which typically requires a temperature controlled deep freezer and follows Biosafety Level 2 safety procedures and precautions. The treating physician must agree to comply with regulatory obligations, including safety monitoring and reporting.

 

For more information on expanded access from the FDA, click here.