At this time, we are not yet providing Expanded Access.
At this time, we are not yet providing Expanded Access.
Once our clinical trials have progressed to Phase 3 and we are able to provide Expanded Access, to be eligible for access to one of our investigational therapies via an Expanded Access mechanism, a physician must certify that the patient for whom the request is being submitted meets the following criteria*:
• The patient has received all available standard treatments without success
• The patient is not eligible to participate in any ongoing clinical study of a suitable investigational therapy
• The investigational therapy requested is part of an active ongoing clinical development program as described on our website
• Provision of the investigational therapy will not interfere with the ongoing development program, and the potential benefits to the patient outweigh the potential risks
* Note that meeting these criteria does not guarantee access to any investigational product.
Receipt of a request will be confirmed electronically within 48 hours. Following receipt of the request, we may require additional information as needed to complete our assessment. Once all of the necessary information is provided for review by our medical experts, a decision for expanded access will be communicated to the Physician within 10-15 business days.