> Is this unusual? It is not unusual at this stage of research. What is unusual is that the EUA process has been used for a product meant for the well. Given

> Is this unusual? It is not unusual at this stage of research. What is unusual is that the EUA process has been used for a product meant for the well. Given that, it seems prudent, at least to me, to release data as if this were closer to the normal and established process. > Who and where? This is a really good start: https://www.youtube.com/watch?v=irSU3a_pVsA https://www.youtube.com/watch?v=irSU3a_pVsA It was very eye-opening to me to hear a BMJ forum focused on how much we still don't know. > Not trying to downplay it, but since it is happening under pressure (from the pandemic) since it is thus unusual it's unsurprising that there will be public criticism from inside the community as well. You say "from the pandemic", but the contents of this leak make it very obvious where the FDA felt the pressure was coming from. They felt they were being "pushed hard by Azar and US GOV". EMA's assessment was that "Azar and still under his influence. Trump is still pulling strings on this." It's right there in black and white: these communications aren't an optimal scientific process. They are scared of the politics and making enormous adjustments. > There is a big difference in trying to understand the scientific results, the state of the art for the sake of understanding and between trying to somehow at some (arbitrary) level 're-evaluate' or 'check' the results and draw a contradicting conclusion. Verify whether all those science guys were right. I don't think that's the nature of individual research on topics of safety and health in the internet age. One needn't second-guess every expert; there is plenty of solid meta-research to consider. What I am saying is that I think I can make better decisions about my own health in the absence of the regulatory capture happening at FDA.