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Posted On: 03/31/2019 2:50:43 PM
Post# of 150052
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Is the Expanded Access Program for Leronlimab on their website new?!
I don't remember seeing this previously, but looks like a way to potentially offer leronlimab to patients that meet the criteria before approval!! Anyone have a contact close to Alex Trebek?
CytoDyn will consider granting Individual Patient expanded access to an investigational medicine only if all of the following threshold criteria are met:
- The patient has a serious or life-threatening illness with no comparable or satisfactory alternative therapies.
- The patient is ineligible for, or otherwise unable to, participate in a clinical trial.
- The patient has a disease for which there is sufficient evidence of a projected benefit from the use of the investigational medicine and the benefit outweighs the known or anticipated risks.
- The investigational medicine is currently in clinical development - that is, it is currently being studied in humans.
- Providing the investigational medicine for the requested use will not interfere with the initiation, conduct, or completion of clinical trials.
- Once a regulatory agency approves a medicine for commercial use, existing expanded access programs will be phased out.
https://www.cytodyn.com/expanded-access-progr...leronlimab
I don't remember seeing this previously, but looks like a way to potentially offer leronlimab to patients that meet the criteria before approval!! Anyone have a contact close to Alex Trebek?
CytoDyn will consider granting Individual Patient expanded access to an investigational medicine only if all of the following threshold criteria are met:
- The patient has a serious or life-threatening illness with no comparable or satisfactory alternative therapies.
- The patient is ineligible for, or otherwise unable to, participate in a clinical trial.
- The patient has a disease for which there is sufficient evidence of a projected benefit from the use of the investigational medicine and the benefit outweighs the known or anticipated risks.
- The investigational medicine is currently in clinical development - that is, it is currently being studied in humans.
- Providing the investigational medicine for the requested use will not interfere with the initiation, conduct, or completion of clinical trials.
- Once a regulatory agency approves a medicine for commercial use, existing expanded access programs will be phased out.
https://www.cytodyn.com/expanded-access-progr...leronlimab
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