In my opinion David, that is a false and premature assumption.
The trial is different for exactly the reasons that the FDA is discussing in its current reform efforts, the issues with patients having too much at stake to join a trial with a true placebo, crossover and other challenges in terms of diagnosis of a difficult Illness for which technologies adapted over the time of this trial, particularly scanning, do not in my view suggest a trial with mediocre results, but rather a trial with what look like stellar results but some challenges based on the legacy of old rules that applied at the start of this trial and are in the process of being reformed not for this trial specifically but for all trials that are like this, many experienced after this trial started.
The issues are obvious to all involved including the regulators I believe, and the challenge is not having to require more of the company, when the results are obvious, simply because legacy rules got in the way. Everyone has done their best to maintain the freedom to adapt the trial because of these things, it appears to me, even to the point of maintaining the blinders until the data lock. The FDA moving early to reform the use of external placebo, etc.
I think, it is likely everyone will be bowled over by the results for a large percentage of the patients and impressed overall with the very substantial gain in survival on average as well.
But the challenge is also reforming it all and presenting the data, and I expect they even have a lot of other data using DCVax outside of the trial that they probably also want to use and can under new rules coming into existence shortly, but the regulatory agencies again are slow. They may decide to pull the trigger sooner, but the most ridiculous result would be NOT to wait for the regulations to catch up and to strand the treatment on the pyre of impatience, setting back care for all cancer patients but especially GBM patients, after a very long trial, much sacrifice, and incredible results. I think no one wants that outcome, even the regulators. I think validating Flaskworks will be incredibly important also to expediting approvals after results are announced. I think they are likely working on all of it with incredible and simultaneous energy, on all cylinders, on a shoe string budget. And someone wants to choke it off.
I think they will have a very compelling case to be made and it will be very exciting for the entire world to see it. I could of course be wrong. All IMHO.
So I see it very, very differently than you do.
