FWIW, this is my take.
I do believe that whether or not the original primary and secondary end-points were achieved, these were subject to concern due to confoundment, crossover, etc. and were too close to call. I don't aver that they failed to be achieved, only that there was doubt. Secondly, milestone survival and especially at OS60 was emerging, if not then recognised, as the more important metric for trial success, especially the length, thickness and spectrum of the long tail. This was particularly important for NICE and strategically fulfilled DC VAX L's role as an adjuvant therapy. Surgery, chemo/radiation were employed to get over the short term hump and DC VAX L was to take care of improvements in longer term survival. Principal investigators clinically witnessed that the vaccine was assisting patients to live longer than they would without the vaccine and that it appeared to work to a greater or lesser degree across a broad spectrum of GBM cancers. This is where NWBO management, the SAB, principal investigators and authors of the JTM interim report believe that trial results will win approval, especially if results are irrefutable. Hence, I believe that management is leaving no stone unturned in making sure the results are irrefutable and approval from the initial 4 RAs reasonably certain.
TLD and how it is presented is of critical importance. it is here where the ball game is played. There cannot be any ambiguity in the long term survival metric and it must be shown to be irrefutable. I can understand the time they are taking to insure this as much as possible and utilising the success of L to significantly shorten approval times for other indications and confidence for off-label indications. In addition, irrefutable results will confer tremendous credibility upon Direct thus enhancing the value of the entire DC VAX platform. Successful TLD will then, undoubtedly, significantly raise the share price and continue to do so through approval and beyond. It will, undoubtedly, invite partnering and perhaps even BO offers although I believe the latter is pre-mature. Conservatively, after release of successful TLD, I believe the SP could rise and settle between $1 and $2, most probably 6 to 8 times multiple over current pps.
I reserve judgement on NWBO management's stewardship thus far. If they bring in impressive results, they achieved the goal. If not, management failed us in this critical moment. Like the captain of a 747, he/NWBO management earn their keep during critical moments of the journey. LP could be in the CEO hall of fame or hall of shame depending upon results. They have only one time to get it right. I am betting that they will and am giving them the benefit of the doubt. I don't sit where NWBO management sits and I don't have all the facts or professional assistance and experience they have. LP, LG, MB, KD, etc. are definitely not stupid people and I trust them much more than MB denizens and other non-professionals who do not even work in the field. It is my strong belief, not certainty, that the trial results will be impressively successful and released at least before the next ASM and more hopefully by the end of this year. I am reasonably optimistic. JMHO.
