I didn't say I predicted it. The discussion started many months ago between AVII, Flip and me, over at IV on PFS psPD. I came across the iRANO change. But that came later. You were probably out of the stock at the time, who knows. OFF a 3/3 post.
I agree with you that Linda Liau was referring to the 149 events. But, I see her "not helping the trial", to indicate that they are not seeing a big range of survival at crossover and so that means most of the survival for the events seen to date is coming before the progression part. But, I also agree that they are not seeing more OS events than anticipated. I've been a broken record about PFS coming in late for this trial due to the inclusion criteria, but that doesn't mean I don't see the vaccine helping treatment cohort patients. I just don't think it's helping the placebo crossover as much as they anticipated it would, and that's where the need to compare DCVax-L's helpfulness after earlier eventing (CUA confirmed rapid group, to death) to later eventing (crossover, PFS to death). The fact that PFS is taking longer than necessary, and tagged along with Les' comments to Drum, about hoping to resume enrolling based on submission, I do see that they could be doing as AVII states and creating a co-primary endpoint for this trial. As for fast track, if the crossover data is a not a wide margin of survival (range of 5-7 months survival afterwards), then they might not have cases where the disease reverses itself at crossover. It could be the mutations evolved and the vaccine isn't helping those patients. The fact that they allow a 3 month video to crossover, it just is too much time for the cancer to progress as far as growth is concerned, and inconsistent crossover vaccine commencement will likely lead to inconsistency on crossover efficacy assuming it is able to help some. But again, none of this crossover possible efficacy shortcomings takes away from the fact that the study designed treatment cohort events with an anticipation that the vaccine group would come in at 13.5 months of PFS and 34 months of OS, with the understanding that > 75% of earlier study DCVax-L patients passed those thresholds. By Linda Liau's comments, this Phase III treatment cohort events can't be coming in much sooner either, as then we would see the overall cohort predetermined events coming in on time. So even if I am correct and greater than >75 % of the placebo came in later than the 7 months PFS and 17 months OS anticipated for that group (let's say 10 months PFS /22 months OS), then they would need at least a fraction greater than >30% of the treatment cohort patients in this study PFS event to come in before the 13.5 and 34 month estimated timeframe, in order to for Linda to be stating something different. That isn't the case here. So, while PFS might be close, OS isn't in jeopardy. If they do change the study to get a co-primary endpoint, it may suck for the short/long term investors, but in terms of a successful study (which is what I really care more about; let's face it, I don't have much money on the line regardless of what folks think), it may prove efficacy. So today, I'm inclined to agree that AVII is correct in the pursuit, but you're correct, that OS is trending fine. It is going to come down to whether they add patients when enrollment resumes. My personal opinion is we are still a good year and a half before the study ends, considering a large part of the study enrollment was done after Woodford's investment and the last statistical change in mid-2014.
I'm not having the patent debate with you again. LOL. You already conceded that I won, and then in a random post to someone else you took it back. I laughed out loud, it was funny. I guess it will take until the end of Phase III for you to admit it is helping patients and traveling to lymph nodes. Whether that will prove to be significance is another story. No one is debating that there are risks that it could fall short.
You blame survival on everything but DCVax-L. The last post you wrote me a group of 68- 73 year old out lives my nephew's 22 months, and you claim they must all be psPD. So magical that a study can just randomly enroll patients at the time of surgery (no exclusion criteria beyond tumor mass) and find 80% of them to be psPDs. Yet that is what you suggested that study did. I'm just glad you're not short. GL to you too. :)
AI
