"Efficacy is paramount for any drug that is being tested in
"Efficacy is paramount for any drug that is being tested in trials for an indication."
I disagree, ClosetInvestor. I believe the FDA's first mandate is to protect the public from "cures" that are worse than the disease. I believe someone on this board found an FDA mission statement to that effect.
I think your statement reflects how people and the FDA perceive their mission in normal times. In emergency times, I think you have to follow the logic Dr. House and Dr. Seethamraju - if the treatment is not worse than the disease and that is all you know about it, you should try it - within reason.
This is especially true if the damage done by not trying something goes beyond the damage done only to the infected. The uninfected are also being damaged during this pandemic economically, psychologically, educationally, socially etc.
If a treatment can be deemed safe, it should be approved for emergency use even if efficacy isn't great or not demonstrated to the last dotted i and crossed t.
This was demonstrated with Remdisavir (or Ramdisacrap as I call it.) In my opinion, Fauci annointed Rem the SOC to get Trump off of the Hydroxycloraqin kick. At least it was not worse than the disease in his estimation. Efficacy? No antiviral action and no impact on mortality. But relatively safe!
You are right about the FDA being the grantor of EUA status but the DSMB will not recommend anything that is unsafe. I have no doubt about Leronlimab's efficacy but a recommendation by the DSMB to end Phase 3 and perhaps recommend a Phase 4 seems to me to be the responsible thing to do. That may indeed go beyond the bounds of normal times and institutional functioning. Isn't that what is called for by being given eIND designation in the first place?
Therefore, I say the main consideration of the DSMB and the FDA should be safety, not efficacy, of which, for Leronlimab, I have no doubt!
Keep Leronlimab on trial but on to Phase 4!
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