The current one being set up at Einstein is a pre-clinical glioblastoma mouse study. It's to prove the potential of leronlimab in glioblastoma to the FDA in order to move on to an actual clinical trial. I would think this would take around 6 months. Then the FDA would have to review the data and the protocol before a human trial could commence.
The best way to obtain leronlimab would be through Federal Right to Try. Under Federal Right to Try the FDA is not involved at all. First step would be to contact Cytodyn to see if they're willing to provide leronlimab. Under the Federal Right to Try law the drug must not be on an FDA clinical hold. Since the clinical hold is only because of protocol approval for HIV immune activation that may not apply to glioblastoma. If it does apply then you'd have to wait to receive the drug after the FDA lifts the protocol hold. Best to contact Cytodyn now because if they're willing to provide leronlimab they can the minute the protocol hold is lifted.
The other avenues would be State Right to Try laws if her state has one. This can be a bit more complicated and time consuming because approval for use may need to be approved by a State medical board or be subject to other red tape. Then there's FDA compassionate use but with time being of the essence Federal Right to Try would be quicker.
The best way to obtain leronlimab would be through Federal Right to Try. Under Federal Right to Try the FDA is not involved at all. First step would be to contact Cytodyn to see if they're willing to provide leronlimab. Under the Federal Right to Try law the drug must not be on an FDA clinical hold. Since the clinical hold is only because of protocol approval for HIV immune activation that may not apply to glioblastoma. If it does apply then you'd have to wait to receive the drug after the FDA lifts the protocol hold. Best to contact Cytodyn now because if they're willing to provide leronlimab they can the minute the protocol hold is lifted.
The other avenues would be State Right to Try laws if her state has one. This can be a bit more complicated and time consuming because approval for use may need to be approved by a State medical board or be subject to other red tape. Then there's FDA compassionate use but with time being of the essence Federal Right to Try would be quicker.
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