That bodes well for success of DC VAX L and a long robust tail. According to the interim article on blinded results, methylated showed impressive results. Out of the ITT total population, methylated comprised about 40% and nearly 45 % of the group that could be classified(N=293). If MES does not significantly overlap methylated, and this molecular sub-group is a relatively large proportion of the GBM stage IV population ranging anywhere from 25%~48%, it may be reasonable to speculate that for at least 50% of the entire population, DC VAX L is highly efficacious. I mentioned this to Les in my telephone conversation and Les said that it gets better than that and they have found that the vaccine works across the entire spectrum. I understood Les to say that MES is separate from the methylated group. Thus it would be additive to methylated. And....MES is most aggressive with least promising outcome on current SOC. This appears to be highly encouraging. It appears entirely reasonable that DC VAX L works particularly well in these two sub-groups, M+ and MES, since in the former, DC VAX L builds upon the Temodar destruction of cellular repair mechanism and that MES is immunogenic with higher levels of T-cells to build upon and a much less suppressive tumour micro-environment allowing more time for T-cell, etc. infiltration before immune response shut down.
I did ask Les when we would get TLD. He told me that NWBO will not specify any timeline. He intimated, but did not specifically declare, that they know when TLD will be released. When I asked whether he could reveal the number of patients still alive as they had previously, he said that now, so close to TLD, they will not release piecemeal information just to mollify frustrated shareholders. They want to release "stupendous"(yes, he used that exact word) information all at once and to catch the shorts unaware. NWBO knows who they are and have amassed considerable and compelling evidence. He said releasing piecemeal good news only gives the shorts opportunities to prepare and short. Releasing "stupendous" information in one fell swoop is what they want to do and will not give any timeline guidance so as to catch them unawares. Management also does not want to run afoul of the SEC by "cherry picking" piecemeal information. Les said that we are on the 3 yard line and they are not going to fumble the ball. They have come too far to risk that so silence, no matter how frustrating it may be and regardless of the share price lack of support, is the strategy they are following until the appropriate time.
He said that the recent FDA statement is highly encouraging for NWBO and there is a 60 day comment period. According to his information, big P is fighting against policy adoption and he wants to get as many people, organisations, etc to comment in support of the guidelines. Les specifically said that if the FDA follows these guidelines, cross-over is no longer an issue. I responded by saying that it should not be an issue anyway. If separation occurs then that is good for the trial depending upon the amount of curve separation. If there is none, it is good for patients, shows powerful efficacy in recurrent GBM even without second resection. So that would be good. He agreed but said that there are forces that will strongly support the letter of the trial parameters and throw the baby out with the bathwater. I am paraphrasing here. I said that is ridiculous but he adamantly said that there are such forces that advocate such perspectives and while "you and I may think it ridiculous, it is just an opinion no matter how reasonable we think it may be." The whole thing is very complicated and frought with landmines-- political, financial and what not--and that is why they need to be meticulously careful. Silence, for now, is the best policy. I responded by saying that many investors, naysayers, etc. interpret silence as hiding something, a scam. Les responded by saying..."you can believe what you want but trust me, there are many different ways for me to make a lot more money legitimately. Why would I risk everything I have worked for to engage in a simple and stupid scam. The spotlight is on us. But if you want to believe I am engaging in a scam, the BOD are aiding and abetting it and the SAB is in on it too, go ahead."
He acknowledged that the SAP took longer than anticipated but that they are extremely pleased with the outcome. He sounded extremely confident. He said that they are going to be extremely careful and make sure everything is right, including timing, before TLD. If it takes another month or so, that is what they will do. I responded, tongue in cheek, "look take all the time you need. I want you to get it right. Rather take two months." Les said "you are close and that is all I am going to say."
There were other topics of conversation which I will keep private.
This is a report of a conversation; judge for yourselves.
