The following are my personal beliefs on why the F
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Posted On: 06/03/2020 2:15:01 PM
The following are my personal beliefs on why the FDA said it would stop approving eIND requests for Leronlimab.
1. It is my understanding that 71 eINDs were approved for Leronlimab and according to my memory Dr. Lalezari had mentioned yesterday how it is unprecedented in a drugs history that they knew the effect of a drug from eIND usage even before the drug had started the trial. I believe this high request rate for eIND had a few effects:
A. Having dealt with multiple government agencies. For me it's not a huge stretch of the imagination that what ever secretary or bureaucrat that was approving the applications probably became overwhelmed and complained about the volume and time it takes to process the applications.
B. There were more approved eINDs approved (71) compared to either trial 58/51. Why is this the case. Enrollment criteria? Or maybe the physicians requesting eIND truly believe in the efficacy of the drug and feel it would be unethical to gamble that there is only a 67% chance that the patient they are personally responsible for receives the medication.
C.In my opinion eINDs undercut the FDAs authority and no agency likes it's authority being diminished. How so? If all that needs to be done for a physician to prescribe an unapproved drug is to fill out some paperwork and this happens on a large scale. The FDA becomes a rubber stamp and in some sense makes them moot.
All of the above is just my opinion
1. It is my understanding that 71 eINDs were approved for Leronlimab and according to my memory Dr. Lalezari had mentioned yesterday how it is unprecedented in a drugs history that they knew the effect of a drug from eIND usage even before the drug had started the trial. I believe this high request rate for eIND had a few effects:
A. Having dealt with multiple government agencies. For me it's not a huge stretch of the imagination that what ever secretary or bureaucrat that was approving the applications probably became overwhelmed and complained about the volume and time it takes to process the applications.
B. There were more approved eINDs approved (71) compared to either trial 58/51. Why is this the case. Enrollment criteria? Or maybe the physicians requesting eIND truly believe in the efficacy of the drug and feel it would be unethical to gamble that there is only a 67% chance that the patient they are personally responsible for receives the medication.
C.In my opinion eINDs undercut the FDAs authority and no agency likes it's authority being diminished. How so? If all that needs to be done for a physician to prescribe an unapproved drug is to fill out some paperwork and this happens on a large scale. The FDA becomes a rubber stamp and in some sense makes them moot.
All of the above is just my opinion
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