Welcome radonculous. I guess your buddy got you buying at the perfect time. Many of us here have not been so lucky. However many of us VERY LONGS, have been fortunate to accumulate multitudes of shares over the years!! And over the years some people, like me, have been lucky enough to follow some of the very smart people here, who have helped me to learn WHY IM NOT SELLING YET!!
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?
Just want him to pick your brain about what your take is on the statistical models that have been presented on this board and the statistics that have been presented by the company. It seems to me that these all point towards a positive trial results.
The case studies of the first three patients are outlined below. Patient A received tumor lysate-pulsed DCVax before imaging and then PD-1 antibody blockade during the interval between the first and second [18F]-CFA PET scans. The posttreatment [18F]-CFA PET scan demonstrated elevated uptake in several peripheral lymph nodes and in the tumor (Fig. 5A) compared with the first scan done 3 wk earlier, in agreement with the results of the murine studies. Advanced MRI revealed an increase in the tumor’s subtraction map (T1+C – T1). MRI with apparent diffusion coefficient (ADC) maps and cerebral blood volume (CBV) perfusion-weighted MRI suggested an almost 300% increase in immune cells in the tumor microenvironment, with the tumor volume remaining fairly constant (Fig. 6A).