i think Jay Lalezari should stop beating his head against a wall in the U.S., trying to get FDA blessing - the well seems somewhat poisoned - at least in the near term. Instead, he should focus his energy on India and Brazil. That is where the lives will be saved at this point - and that is where we desperately need a credible source backing our drug, after the FDA letter.
You never know - having a guy that impressive (who is also objective) speak with some key thought leaders over in those markets could mean the difference between an EUA in the near-term and a long, drawn out trial process. And that could save 10s of thousands of lives.
I don't know him, but if anyone else does - maybe it's worth checking in on that.