Expanded Access Policy

Kalevala Therapeutics evaluates requests for expanded access to its investigational drugs on a case-by-case basis, consistent with FDA regulations (21 CFR Part 312, Subpart I).

Contact Information

Expanded access requests should be submitted by a licensed physician to:

Kalevala Therapeutics, Inc.
Email: info@kalevalatherapeutics.com

Request Procedures

Physicians seeking expanded access for a patient should email the above address with the patient's diagnosis, treatment history, and clinical rationale for access to the investigational drug.

Evaluation Criteria

Kalevala Therapeutics evaluates each request based on:

• Whether the patient has a serious or life-threatening condition with no satisfactory alternative treatment
• Whether the potential patient benefit justifies the potential risks
• Whether providing the drug would compromise ongoing or planned clinical trials
• Whether sufficient supply is available

Acknowledgment Timeframe

Kalevala Therapeutics will acknowledge receipt of a request within 5 business days.

Clinical Trial Information

Information about Kalevala Therapeutics' clinical programs and expanded access availability can be found at ClinicalTrials.gov.

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This policy does not guarantee access to any investigational drug. Expanded access is subject to FDA authorization. Kalevala Therapeutics may update this policy at any time.