Misiu, I was trying to think of how best to respond to dadbrotheroftwins question about other countries stepping up if the FDA fails to approve. I know that I believe another country would but I wasn't sure how to effectively express it so I did not. Your response was, in my opinion, spot on correct.
1. Big problem, getting bigger with mutations.
2. Mortality a global concern and apparently getting bigger with mutations.
3. Leronlimab/Vyrologic's MOA becoming widely known and understood and gaining traction. This fact alone will begin to make it hard to ignore and the demand will become too great.
4. Safety is undeniable.
5. Efficacy soon to be proven via CD-12 results but already undeniable by many, especially the folks who have directly benefitted via EIND.
I'm not saying if the FDA doesn't approve that it won't slow us down but I don't believe for a minute that it will stop us. It would be just another hurdle that, in my opinion, will be successfully cleared. I have a feeling though that because of the aforementioned reasons, and probably more I haven't listed, that the FDA will find it hard to legitimately deny EUA and eventually full approval.
These are just my opinions.