Replies to post #161586 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

I think it's not Linda's call. I think the DMC is telling (recommending) people exactly what to do at this point. AVII has provided some pretty interesting reading/dialogue from DMC trial control. One would be ill advised to dismiss their direction late in the trial.

Besides. Unless there was a mid-trial trial manufacturing (aka: efficacy) improvement, imo, there are likely no more original placebo patients left to PFS event, and likely only six (give or take) original placebo patients alive (regardless if they crossed over or not.) How on earth could unblinding have any impact on trial integrity under such circumstances at this late stage in the trial? Remember me....I'm the one that went on for years about preserving trial integrity. They can still collect data after unblinding.

On the other hand, if there was mid-trial improvement, hopefully the single arm whole trial analysis will capture its impact in a front to back style analysis. It might actually be more dramatic if this occurred.

JMHO.

[Ultraz2]

Hmmm...will be behind 8 ball soon!

Phase 3 randomized, controlled registration trial with TSC and SOC chemotherapy and radiation, compared with SOC alone in 236 patients newly diagnosed with inoperable glioblastoma multiforme (GBM), a type of brain cancer, is underway. A Phase 2 clinical program was completed in the second quarter of 2015 and evaluated 59 patients with newly diagnosed GBM. This open-label, historically controlled study demonstrated a favorable safety and efficacy profile for TSC combined with SOC, including a 37% improvement in overall survival compared with the control group at two years. A particularly strong efficacy signal was seen in the subset of inoperable patients where survival of TSC-treated patients at two years was nearly four-fold higher compared with the controls. Due to its novel mechanism of action, TSC has safely re-oxygenated a range of tumor types in preclinical and clinical studies. Diffusion believes the therapeutic potential of TSC is not limited to specific tumors, thereby making it potentially useful to improve SOC treatments of other life-threatening cancers. Additional studies under consideration include Phase 2 trials in pancreatic cancer and brain metastases, with study initiation subject to receipt of additional funding or collaborative partnering. The Company also believes that TSC has potential application in other indications involving hypoxia including stroke, where the Company recently announced its PHAST-TSC study which will be conducted in co-operation with the University of California Los Angeles (UCLA) and the University of Virginia (UVA) to test TSC in stroke patients in an in-ambulance clinical trial setting.