NorthWest Biotherapeutics Inc (NWBO)

[beartrap12]

Flipper, I read your original statement and it makes a great deal of sense to me. I was also glad to see you explain it again. You're not suggesting, as Pyrr says, that NWBO has never had an adequate trial design. What you're saying is that DCVaxL can't be approved for commercialization until they have the commercial plant ready to go. Then the commercial plant itself must be approved by the FDA before they can produce even one commercial product. We know that Memphis has been making the vaccine for the trial, but they have to prove to the FDA that the product is consistent and they can produce thousands of personalized vaccines. This has never really been done before, so it's groundbreaking for manufacturing, as well as the science. I can imagine that there is some back and forth between FDA and the company. You're suggesting that this silence is similar, but longer, than what we experienced when they went from a Ph 2 to a Ph3 trial, so perhaps now they're moving to commercialization ....and approval. And we have to wonder if they're trying to get all locations up at once, or just one to start.
I agree. It's the most plausible idea for the silence I've heard on this board.