From the Frequently Asked Questions "Is leronli

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"Is leronlimab, an unapproved drug, currently available to the public outside of a clinical trial?

As an unapproved drug, leronlimab is not available to the general public. However, certain patients who are facing serious illnesses, and who have exhausted all available treatment options, may be able to receive early access to investigational drugs that haven’t yet been approved by government regulatory agencies. The FDA allows for two options for treating patients with an unapproved drug, biologic or test article outside of a clinical trial. One option is “ Expanded Access .” The other option is “ Right to Try .” For additional information about potentially obtaining leronlimab, through your medical provider, under an Expanded Access allowance, please feel free to email: dai@cytodyn.com.

For the most up-to-date information regarding The Right to Try Act , and/or potential access for patients who have been diagnosed with life-threatening diseases or conditions, have tried all approved treatment options, and are unable to participate in a clinical trial to access certain investigational treatment options, please visit FDA.gov and review its overview regarding “Right to Try” allowances. https://www.fda.gov/patients/learn-about-expa.../right-try

WARNING: Leronlimab has not received regulatory approval from the FDA. The potential risks and benefits are not known. Doctors and patients should consider all possible benefits and risks before applying for expanded access (or right to try) to leronlimab."

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