I think the eIND process varies slightly by indica
Post# of 153815
(Total Views: 462)
Posted On: 02/08/2021 1:12:32 PM
I think the eIND process varies slightly by indication. I am guessing you are referring to eIND access for S/C COVID, which if that is the case and you have a trial site close by I would recommend going to that hospital as they are familiar with the qualification criteria and leronlimab and don't have to do an individual eIND request. If not near a trial site, I understand it is an individual request from the doctor coordinated through Amarex and Cytodyn to the FDA for eIND authorization. I too would like to know other people's experience with step-by-step notes to keep handy in case needed urgently.
I will share my recent experience in regards to requesting access to leronlimab for a family member with stage IV pancreatic cancer. I emailed the contacts listed on the clinical trial website and Dr. Jay (I had his email from a previous inquiry about the expanded access breast cancer trial). I emailed on a Saturday and had a response from Dr. Jay that day. He said they are only accepting local patients in the cancer basket trial due to COVID and put me in contact with two POCs (one at Amarex and one at Cytodyn) to see if my family member would qualify for eIND access. I did not receive a response from them until sometime the following Monday afternoon. To determine if my family was qualified for eIND access, they requested the oncologists contact info or for me to provide their contact info to the oncologists to coordinate and evaluate eligibility. My family member is very early in the process and the treatment plan isn't known or initiated yet. The oncologist is not pursuing the eIND process for leronlimab currently. I intend to push the eIND again once the treatment plan is established and see how well my family member responds....or if CD12 results are announced and PE hit or EUA issued as at that point leronlimab will be viewed as having FDA endorsement and not some random trial drug. It is very frustrating that some doctors will not even consider trial drugs regardless of the limited approved treatments, especially given the safety of leronlimab and that it can be combined with whatever other standard of care treatment they recommend.
I will share my recent experience in regards to requesting access to leronlimab for a family member with stage IV pancreatic cancer. I emailed the contacts listed on the clinical trial website and Dr. Jay (I had his email from a previous inquiry about the expanded access breast cancer trial). I emailed on a Saturday and had a response from Dr. Jay that day. He said they are only accepting local patients in the cancer basket trial due to COVID and put me in contact with two POCs (one at Amarex and one at Cytodyn) to see if my family member would qualify for eIND access. I did not receive a response from them until sometime the following Monday afternoon. To determine if my family was qualified for eIND access, they requested the oncologists contact info or for me to provide their contact info to the oncologists to coordinate and evaluate eligibility. My family member is very early in the process and the treatment plan isn't known or initiated yet. The oncologist is not pursuing the eIND process for leronlimab currently. I intend to push the eIND again once the treatment plan is established and see how well my family member responds....or if CD12 results are announced and PE hit or EUA issued as at that point leronlimab will be viewed as having FDA endorsement and not some random trial drug. It is very frustrating that some doctors will not even consider trial drugs regardless of the limited approved treatments, especially given the safety of leronlimab and that it can be combined with whatever other standard of care treatment they recommend.
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