Here's some sauce for you: "https://www.fda.gov/media/151710/download" One of the first paragraphs under "Licensing" says it is approved in Germany and it will be packaged in Belgium - that doesn't sound like the US to me. Not to mention all of the "safety" testing for myocarditis and pericarditis, which they obviously new was a problem going into this.
Here's some sauce for you: "https://www.fda.gov/media/151710/download" One of the first paragraphs under "Licensing" says it is approved in Germany and it will be packaged in Belgium - that doesn't sound like the US to me. Not to mention all of the "safety" testing for myocarditis and pericarditis, which they obviously new was a problem going into this.