We continually evaluate the benefit-risk profile of our investigational drug(s) based upon
evolving clinical data. The fact that an investigational drug is made available for the
treatment of a particular patient does not mean it will be made available in response to other
requests on behalf of other patients whose circumstances and medical histories may be different.
Requests will be considered on a case-by-case basis.
Palisade Bio is committed to evaluating all requests in a fair and equitable manner. All requests must be
submitted by the patient’s treating physician; PB 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 consent, patient monitoring and safety reporting. Each request will be given
careful consideration by PB, whose decisions are final.
Physicians seeking pre-approval access for patients with no alternative treatment options should
submit their requests to safety@palisadebio.com. We regularly
monitor this mailbox, with the intent, as reasonably possible, to acknowledge each submitted
request within 5 business days of receipt, and to review and respond to each proper request
within 10 business days of receipt.