NorthWest Biotherapeutics Inc (NWBO)

[Da_Hooey]

Agree Bio.

ExW: What FDA cares about, both in general and in particular Dr. Pazdur, is if desperately sick patients survive, even more so if that's with quality of life, and many for years - and even more so without a significant toxicity risk. Having mechanistic data and histopath in support of MOA is a nice-to-have, not a have-to-have, for a toxicity-less successful treatment for a heretofore virtually unsurvivable tumor. And as Bio suggests, NW will have it - Liau and Bosch and Prins and Cobbs and Brem et al already have much of it, and it will be made available in the fullness of time.

But they sure as hell don't need it. Not for this they don't. Patients with beating hearts at 5 years are patients with beating hearts at 5 years - not a single patient in the 2000+ patients across fifteen nd and rGBM control studies made it to 5 years. Not a ONE. NW had TWENTY SEVEN out of 331 alive at 5 years.

Dismissing that as "academic success" is simply beneath contempt. Those are real people - living instead of dying.