CFR https://www.accessdata.fda.gov/scripts/cdrh/c...?fr=312.42

Amerex issues? We got to BLA submission stage so i dont see how its a safety or efficacy issue. There's too much data on safety and efficacy. It has to be something procedural IMO. Or just another brick in the wall that fda and bp are building around us.

We cant give LL with no safety signals to people in a study to determine its safe but we can use force of government coercion to put non approved (eua only) vaccines in people that day by day are turning out to have all kinds of documented but hidden safety concerns. All my conspiracy theories keep coming up true.