Expanded Access and Compassionate Use Policy

Shivanka Research is committed to developing transformative treatments to address the unmet medical needs of patients suffering from rare and serious diseases.

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Clinical trials allow us to evaluate investigational treatments in order to generate the information needed to determine their safety and effectiveness, and to obtain regulatory approval. We believe the best way for patients to access investigational treatments is through participation in these clinical trials. However, when patients are unable to participate in clinical trials and have exhausted all available treatment options, health authorities may permit Shivanka Research to consider providing your physician access to an investigational product outside of a clinical trial. We refer to this process as expanded access, and sometimes referred to by others as compassionate use. The expanded access must be made by a physician on the patient's behalf.

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Shivanka Research will consider expanded access requests outside of a clinical trial when all the following criteria are met:

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·        The patient has a serious or immediately life-threatening disease or condition;

·        There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition;

·        The patient is not eligible or cannot participate in an ongoing or planned clinical trial;

·        There is sufficient scientific evidence that the potential patient benefit justifies the potential risks of treatment;

·        This expanded access use will not interfere with clinical trials that could support the development or marketing approval of the investigational product.

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Shivanka Research is committed to evaluating all requests in a fair and equitable manner. All expanded access requests must be submitted by the patient's treating physician, and we will generally only consider requests if the investigational drug is in active clinical development with sufficient data available to determine an appropriate dose and schedule for the patient's specific condition. Shivanka Research may require more detailed information in order to fully evaluate a request. The requesting physician must agree to obtain appropriate regulatory and ethics committee approvals and comply with regulatory obligations, including obtaining patient informed consent, medical monitoring, safety reporting, and data collection. Each request will be given careful consideration by Shivanka Research.

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Physicians seeking expanded access to a Shivanka Research investigational treatment should submit their requests to ganeshs@shivankaresearch.com.

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Shivanka Research will acknowledge a request within 5 business days after receipt of the complete request. This request should indicate the date of request, the requesting physician contact information, and a medical rationale for request including an explanation for why the patient cannot qualify for a clinical trial and why no alternative can be used.

Information about Shivanka Research clinical trials can be found at https://clinicaltrials.gov/.