NorthWest Biotherapeutics Inc (NWBO)

[anders2211]

GOOD you have admitted to being WRONG on you strange assertion that the moment L is approved for GBM NWBO will NOT have approved access to a 450 billion market for solid tumors in other organs. Good now lets tackle the next.

Studies take YEARS as a general principle. Its very rare that any form of accelerated or provisional approval will be granted. The biggest change is that the FDA will stick to its guns and stay with the order of things as they have it now in place which is years. Ex says 7 I stick with 5 years out. I look at how the FDA has been treating other studies and I stay with 5 years.

BKR says this:

No not simultaneous approval. That would be irresponsible. However, according to the Cures Act, this dendritic cell vaccine can get a kind of expedited approval for all solid tumors without phase 3 studies via the success of dcvax-L and cheaper and faster non RCT studies amongst other approved real world evidence gathered from Dcvax-L.

I agree with that. But 5 years.