jiroen schreef op 20 november 2020 10:40:
Byfavo is approved in the US for procedural sedation, not for general aenesthesia.
Now, based on these results in Europe, there is an opportunity for Acacia to develop this product for general aenesthesia in the US, too.
Acacia will never commercialize Byfavo in Europe (Paion retains the rights). But they could get a new indication for the US market. However, a Ph3 study in the US will be needed.