SonALAsense, Inc.

Expanded Access Intelligence

Reagan-Udall Foundation Insights

Company
SonALAsense, Inc.
Additional Information

Single-Patient EA Policies/Criteria In very specific cases, SonALAsense may be able to provide access to our investigational drug outside of our clinical trials if certain conditions are met. Single Patient Expanded Access may not always be available as each patient is unique and this will be at the discretion of a physician based on many factors and conditions. To be eligible for access to the investigational medicine, a physician must apply and certify that the patient for whom the application is being submitted meets the following criteria: Diagnosed with a serious, life-threatening or severely debilitating disease; 1. Unable to participate in SonALAsense clinical trials; 2. Have no comparable or satisfactory alternative treatment option available; 3. The risk/benefit profile of the investigational drug is favorable in light of the sufficient safety and efficacy information and the treating physician’s assessment of the patient’s medical condition. Available Therapies via Single-Patient EA Diffuse intrinsic pontine glioma Recurrent or progressive glioblastoma

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