I disagree with this piece on 3 vital points. 1) The EUA was not needed to try convalescent plasma on patients, due to numerous unfilled clinical trials and one of the largest ever expanded access programs; 1/5 https://twitter.com/Slate/status/1298806085239869440

2) The availability of convalescent plasma outside of trials will hinder the enrollment of randomized trials. Full stop. They were already having trouble with enrollment; this is their death knell. 2/5

3) Stating that the FDA could have required more data collection, or limited the EUA to a trial setting, doesn’t change the fact the FDA didn’t do this. And this is a big problem, as we will go on using cp without learning how well it works 3/5

The EAU as such a low bar that my opposition to it in this case isn’t on the grounds of insufficient high quality data but that it will prevent the collection of high quality data in a nation w/ enough cases that we could complete trials rapidly if we got out of our own way 4/5

So, I agree that EUAs are intended to fill a short-term, time-sensitive roll specifically because they’re more nimble than most trials. But I don’t agree that the decision to grant this EUA was appropriate, as it will further impede trials & patients were already able to use CP 5