NorthWest Biotherapeutics Inc (NWBO)

[j e d]

I'd love to be proven wrong, but I don't see how we're getting an MA decision before mid/late July given that the MHRA is seeking feedback on using RWD-based ECAs with a deadline of June 30. For them to put out this request, and then make a decision on an application using a RWD-ECA before receiving the feedback would be very odd imo.

Too, I am confused why they would requesting this now, a year after the CHM meeting on DCVax? Not being bearish or bullish here, it just makes no sense either way. By doing this at this point they're putting themselves over the 210-day mark (deadline of June 30 or so), and I see no reason why if they needed to do this for scientific or political reasons, to not have done it last year.

Does anyone have a legit explanation for this? (And not the "technically DCVax isn't using RWD" argument—within MHRA's RWD definition they have an aside saying they mean data from previous clinical trials too. They want feedback on all ECAs.)