NorthWest Biotherapeutics Inc (NWBO)

[jammyjames]

"She said it Jimmy"

I never said she didn't

"So, a part of it is having the FDA think a little bit differently about what constitutes approval. On the converse, like the Optune device, that Novocure device, is FDA-approved. But I must say a lot of patients are like, “Well, I don’t really like it.” And I think on the physician side, we just don’t understand how it works and there are a lot of problems with the clinical trial design.

There was no true placebo arm, but they did design it in a way that met the FDA checkboxes. So, it was approved, but a lot of us don’t really believe that it works. I think it’s one of these things where if your ultimate goal is to cure GBM, it’s hard to reconcile all these different factors; the regulatory factors, the financial factors, as well as the science and the biology of the tumor itself, which is very complex."

She said it very matter of fact. I'd generally agree with everything she said. I however think it works just not as well as shown by the trial data. i'd have done exactly as the EMA/NICE did...EMA approved it..NICE refused to pay for it.