Not approved as a drug.. But NWBO uses it in manufacturing for Direct so does not need approval as a drug..
But even worse for your argument, last I checked Sawston is located in the UK. In the UK, the approved BCG vaccine comes from AJVaccines in Denmark. So what does Merck have to do with this? What does the FDA approval have do with this?
Any way you cut it, the world has a sufficient supply of 300M doses a year. The idea NWBO cannot find a few hundred to run a P2 trial is funny.