New EU acceleration efforts. The EU has been slower than the US in its permit bureaucracy, and this is one attempt to speed things up.
FAST EU (Facilitating and Accelerating Strategic Trials in the EU) starts in a week as a pilot. The requirement is at least 2 EU countries in the trials. At least BEXMAB-2 and Nordic AML could benefit. BLAZE, of course, is non-EU. BEXAR is only Spain. FINPROVE is only Finland.
The FDA doesn’t care about these, but the regulatory process carried out with the FDA could, with adaptations, be suitable for an application here. Bono at least seems to have noted this. The paperwork requires effort, but the possibility of accelerating market access sounds good to everyone, even if there is limited room in the pilot right now.