The drug exists, but not the legally distinct product that received FDA approval. FDA mentioned this in their statement, so it's not playing semantics. They need to provide a complete list of ingredients, a list of risks (at least Myocarditis and Thrombosis), receive acceptance from FDA on those, and then package and ship.
I don't know if there is less liability immunity with the approved version if/when available. Long-term trials, including for pregnancy effects will be "complete" 2025, and 2027. I put that in quotes, because they halved the current trial.
The drug exists, but not the legally distinct product that received FDA approval. FDA mentioned this in their statement, so it's not playing semantics. They need to provide a complete list of ingredients, a list of risks (at least Myocarditis and Thrombosis), receive acceptance from FDA on those, and then package and ship.
I don't know if there is less liability immunity with the approved version if/when available. Long-term trials, including for pregnancy effects will be "complete" 2025, and 2027. I put that in quotes, because they halved the current trial.