austinmediainc,
Do you remember when I suggested that one of the strategies that I thought NWBO would play is to get the trial ethicist to become proactively involved for positive reasons to put the onus of ending the trial on regulators? I said this because Linda stated that she would not end the trial early and would only apply for AA when the trial was completed. This suggested to me that a regular approval path was still being contemplated but would change to AA if everything lined up with all the necessary approvals for manufacturing and commercial ramp plan.
OS eventing has been delayed according to Dr. Linda Liau and as Rkmatters has pointed out this would mean that OS eventing for the entire group is taking longer than 28.33 months according to the original protocol that Rkmatters shared. Remember Pyrrhonian said one trial, the best he could find, showed 30 months median OS for control (treatment arm did worse), well Dr. Liau's comments were from back in October of 2015 and we still do not have 248 progressions reported, which most agree would be a material event, so rest assured that the 9 months that have passed since Dr. Liau's comments is very significant. The OS for the entire group Pyrrhonian mentioned was less than 30 months. If the entire group is living longer than 28.33 months on average then the comments Dr. Liau made were pointing to patients living longer than the best trial results ever recorded and that was 9 months ago which was about 2 months after the discovery of the screening halt. Now couple this with the fact that the parallel pseudoprogessor trial, with more mature data, also did not fully enroll and the chances that an ethicist intervention and regulator actions occurred rise dramatically. If this did occur, then pseudos went to the EAMs program which several posters indicated did happen and Phase 3 treatment arm may have continued enrolling after the screening hold but not the SOC arm if a large enough trending gap in OS had been observed by regulators if they peeked. With this action in place the company would need to wait for events to continue to accrue and report these events on a regular basis to regulators. If SOC was no longer being given then the possibility that a few spaces were left for SOC plus crossover option, to be filled if needed for powering, still exists. The final decision then would be a stop for efficacy (without resumption), "continue" for powering or neutral determination (resumption) or "futility" (no resumption). Futility seems to be a very remote possibility with the evidence from above so that leaves 2 options which are either a positive stop or a neutral to slightly negative continue. The possibility exists, therefore, that an ethicist working on the trial for NWBO may have approached the company to suggest a halt but Linda refused.
Linda has stated that she wants to finish the trial and there are good reasons to do this as recent comments from FDA about regular approval applications suggest. Linda would want FDA to make a determination if she thought the time spent reviewing data might help improve final determined PFS and or OS benefit and chances at approval. Under this sceario Linda would have some idea that positive findings might be expected but would not know when the exact time for median(s) or other statistically significant trends would be found as this would be partially determined by when regulators decide a peek is necessary and what they find. The final decision, and the screening hold of course, would be in the hands of regulators whether or not NWBO remains blinded through this process. Would the company even hint at this if this was the case? Of course not because trial integrity is at stake and powering of the trial may be as well to a small but potentially significant amount so crickets. In the mean time the hunters and trappers quietly follow the tracks and listen for the howls. Best wishes.
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