Theory: The FDA has already approved LL for covid.
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Posted On: 12/23/2020 2:14:14 AM
Theory: The FDA has already approved LL for covid.
Or else why would the FDA authorize EIND?
The FDA must have some plan for CD12 patients who request an EIND to make sure they get LL and not placebo.
There is no doubt that some, perhaps most, of the CD12 patients are in the trial specifically because they wanted access to leronlimab. There is no doubt that some CD12 patients sought out the trial specifically because they wanted a chance to get leronlimab. EIND approval changes their calculus dramatically.
Any physician who denies a CD12 patient's request for an EIND, or who does not request an EIND, is in severe violation of his/her Hippocratic oath.
The only appropriate response to a CD12 patient request for EIND is to approve the EIND request. Surely the FDA must recognize this.
And just as surely the FDA must recognize that approving a CD12 patient EIND request runs the risk of blowing up the CD12 trial.
No way the FDA risks blowing up the CD12 trial unless the FDA has already made the decision to approve leronlimab for covid.
The EIND is likely a cover-your-ass move on the part of the FDA.
When results are published on Jan 12 or soon thereafter, LL will get approved and people will ask: Why wasn't this approved sooner?
And then the FDA can answer: We broke our standard protocols to accelerate the availability of leronlimab by offering EIND while the trial was still running.
Even with this answer the FDA may still get crucified. Imagine if one of the CD12 placebo patients dies and then after the patient's death, the family finds out that LL EIND was approved and their family member could have obtained leronlimab instead of placebo.
Or else why would the FDA authorize EIND?
The FDA must have some plan for CD12 patients who request an EIND to make sure they get LL and not placebo.
There is no doubt that some, perhaps most, of the CD12 patients are in the trial specifically because they wanted access to leronlimab. There is no doubt that some CD12 patients sought out the trial specifically because they wanted a chance to get leronlimab. EIND approval changes their calculus dramatically.
Any physician who denies a CD12 patient's request for an EIND, or who does not request an EIND, is in severe violation of his/her Hippocratic oath.
The only appropriate response to a CD12 patient request for EIND is to approve the EIND request. Surely the FDA must recognize this.
And just as surely the FDA must recognize that approving a CD12 patient EIND request runs the risk of blowing up the CD12 trial.
No way the FDA risks blowing up the CD12 trial unless the FDA has already made the decision to approve leronlimab for covid.
The EIND is likely a cover-your-ass move on the part of the FDA.
When results are published on Jan 12 or soon thereafter, LL will get approved and people will ask: Why wasn't this approved sooner?
And then the FDA can answer: We broke our standard protocols to accelerate the availability of leronlimab by offering EIND while the trial was still running.
Even with this answer the FDA may still get crucified. Imagine if one of the CD12 placebo patients dies and then after the patient's death, the family finds out that LL EIND was approved and their family member could have obtained leronlimab instead of placebo.
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