Well We Now Know They Didn't Use The Wrong Comparator
The shorts now have nothing..... I don't know why the FDA is stuck in the 1920s and have to make NAVB go through this entire process. I don't understand why they couldn't approve the drug contingent on getting the manufacturing taken care of. That would be too efficient. They want the money of a resubmission no matter what is costs a small company trying to help people.
Typical inefficient government thing...we're such a rich country that we can be so wasteful like this. In some ways, I think FDA prefers to do it this way so that they can carry many wasteful employees.