I think the idea that the company can determine the date the trial is unblinded is wrong until the SAP is agreed upon by the regulators. I'm of the belief that the company can't say, here's the new acceptance criteria, you must accept it, they must submit a draft SAP and change anything the regulators request before they have a final SAP, and they must have that final SAP before they unblind.
If they have the SAP accepted by the regulators, then they can unblind on any date of their choice, and I cannot believe they will necessarily wait for precisely 4 years after the last patient added if it costs them the ability to present the data at SNO, the ideal technical conference for presenting it.
I don't know precisely how many people are still alive, but I hope it's still in the 80's. Regardless, I believe the clinicians, but not the company, know the full status of all who've previously passed away. They know if when they initiated in the trial if they got the vaccine, or if they crossed over, or never got it. I believe at the push of a button they can generate the K-M curves on all these people. Of those surviving they may not yet have that knowledge in full, but I believe once you unblind the trial they can put it together in a matter of days.
I'm suggesting that once you have the SAP, all the other things that need to happen before a full presentation of the data at SNO can be done in a few weeks. The key is an SAP accepted by the regulators, unblinding could occur on the very next day, or might wait to the point where they're convinced they can do a full presentation at SNO to get the maximum credit for those remaining alive, but at this point a few days makes very little difference. The numbers of people who're currently alive, plus all those who lived 4, 5, 6 years or more but have now passed on will clearly show the benefits of the vaccine over the SOC.
I have no idea whether the patient that's currently the longest living patient in the trial is still alive, it's certainly possible, but it's also possible that someone who entered the trial over a decade ago passed on recently, perhaps for something totally unrelated to GBM. We don't know if the longest living patients have been judged to be disease free, or still considered to be fighting the cancer. My point is, we have much to learn, but I believe the clinicians do know all these things, and more, and once unblinded, it can all come together in just a matter of days.
Last week I had a BCR-ABL test, it determines if I have any blasts down to .0001%, and it's been negative for over 4 years since I received stem cells. It can be said I'm cancer free, but I'm still taking chemo, and statistically if I stop, the odds of the leukemia returning increase. That's true at 5 years, and longer. I mention this because I really don't know that you ever can say you're cured of a cancer. The fact that no sign of it can be found is great, but I don't know that you can ever say it's a cure.
Gary
