[BostonCard]

The Trump admin is pushing for EUA's for these meds already. The Regeneron one is not the Lilly one, but if this mAb is not helping, I would be surprised if Regeneron's is the "cure" that Trump is selling. And once an EUA comes, we may not know how effective the meds are since we won't be testing it in a controlled trial. Maybe overseas studies would still continue and give us some insight.

I would imagine the vendors will continue clinical trials because an EUA isn't an ideal way to receive compensation for a drug. Insurance companies want "approved" therapies. In some cases the EUA makes it hard to recruit patients because you don't have to be on a trial to get the treatment. In this case I think there are enough patients in the USA that won't be a problem. Could also be a problem if having a "placebo" group is considered unethical, but I would imagine a drug would have to truly and obviously be a "game changer" for that to happen.

The issue isn't what the Sponsor wants to do; it is what patients want to do once EUA is available.  Given a choice between a clinical trial with a 50/50 (or, at best, a 2:1 odds) of getting the active drug or knowing you are getting the active treatment under an EUA, most patients will elect to get the treatment.  The issue is if there is limited availability of the treatment through the EUA, and the choice facing the patient is a clinical trial or nothing.

BC

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There is some precedence of monoclonal antibodies failing in clinical trials of respiratory diseases:

https://aac.asm.org/content/64/7/e00352-20

(disclosure: I am one of the authors on that paper)

BC

[BostonCard]

The Trump admin is pushing for EUA's for these meds already. The Regeneron one is not the Lilly one, but if this mAb is not helping, I would be surprised if Regeneron's is the "cure" that Trump is selling. And once an EUA comes, we may not know how effective the meds are since we won't be testing it in a controlled trial. Maybe overseas studies would still continue and give us some insight.

I would imagine the vendors will continue clinical trials because an EUA isn't an ideal way to receive compensation for a drug. Insurance companies want "approved" therapies. In some cases the EUA makes it hard to recruit patients because you don't have to be on a trial to get the treatment. In this case I think there are enough patients in the USA that won't be a problem. Could also be a problem if having a "placebo" group is considered unethical, but I would imagine a drug would have to truly and obviously be a "game changer" for that to happen.

The issue isn't what the Sponsor wants to do; it is what patients want to do once EUA is available.  Given a choice between a clinical trial with a 50/50 (or, at best, a 2:1 odds) of getting the active drug or knowing you are getting the active treatment under an EUA, most patients will elect to get the treatment.  The issue is if there is limited availability of the treatment through the EUA, and the choice facing the patient is a clinical trial or nothing.

BC

---

There is some precedence of monoclonal antibodies failing in clinical trials of respiratory diseases:

https://aac.asm.org/content/64/7/e00352-20

(disclosure: I am one of the authors on that paper)

BC