• The clinical situation of the patient for whom the treating physician seeks access, including whether all approved therapy or clinical trial options have been exhausted
• Whether the treating physician believes that the potential benefits of our investigational drug will outweigh any potential risks to the patient
• The ability of the treating physician to adequately communicate to the patient the potential risks and benefits of the proposed use of our investigational drug so that the patient can provide informed consent and the willingness of all parties to sign a release for such use
• The ability of the treating physician to deliver our investigational drug locally utilizing techniques such as ultrasound guided injection that are being established in our clinical trials
• The likelihood that regulatory authorities and institutional review boards (IRB’s) will review and approve expanded access for the patient in a timely fashion
• Our past experience with the site IRB and the commitment of the treating physician to obtain IRB approval and maintain an investigational new drug (IND) application
• The available supply of an investigational drug
• The impact of providing expanded access on resources devoted to our development programs 
• Other factors NanOlogy may deem appropriate in our sole discretion

NanOlogy reserves the right to revise or discontinue this policy without notice.