NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

The FDA is, for the near future, the most unlikely to submit a BLA, for the simple reason of the absence of patient-level data that's just a simple fact. The EMA will be delighted to adopt the MHRA findings. I suspect the EMA will approve DCVAXL 6 months after they have submitted an MAA, provided the MHRA will recommend DCVAXL (which I'm sure they will).

I don't see the NWBO submitting a BLA as long as they are an independent biotech. I believe that after NWBO has been acquired, after EMA approval, the new owner of NWBO will submit a BLA.