NorthWest Biotherapeutics Inc (NWBO)

[Evaluate]

Hi Radonculous. you wrote:

In addition to being a physician, I also have an MPH in epidemiology and have a lot of experience with clinical trials, study design, statistics, etc.
Feel free to ask me any questions.

Since you offered ...
What are some of your thoughts in regards to finalizing the SAP's?
Do you feel enough time has gone by that NWBO may have already submitted these to the 4 Regulatory Agencies?
Do you think that NWBO may have already received revised SAP approval from any/all 4 RAs?
What main revisions do you believe NWBO might be incorporating in these revised SAPs?
How to statistically interpret PFS events & pseudoprogression?
Surgery with/without dyes (5 ALA)?
White blood cells counts?
Other factors?
What is your current expected timeframe for topline/data lock? From the PR it appears this will not be announced at ASCO ... are you thinking perhaps within weeks, or perhaps towards year-end?
Statistics: which of the trial results do you believe might have improved compared to their most recent blinded results disclosed?
Do you think that Primary Endpoint (PFS) might still come through OK? Or that the long tail of OS will need to "save the day/trial"?
Once unblinded, where do you figure the OS results might wind up for:
Treatment Group (early DCVax)?
Placebo Group (no DCVax versus Late DCVax)?

Assuming approval of DCVax-L, which country/RA do you believe might grant approval first?