Doc,
I didn't say it earlier, but if our oldest survivor received the DCVax-L 25 years ago, this is almost more like a crime than a clinical trial. Can you imagine it's taken a quarter century to bring a life saving product to near approval. Why in the world haven't the medical experts all over the world recognizing what's been happening here and done something to expedite it by a decade, or more.
I can't believe all these people living went unnoticed, I'd be willing to bet that at the time of the halt the Germans, who insisted that all patients get the vaccine from the get-go would have preferred to end the trial right then and there, and make the vaccine available to all. This is speculation on my part, but it's clear that the four regulators all agreed to the changes, even if the company didn't formally document them until shortly before the trial was formally ended. They actually were caught off-guard when the UK and Germans upgraded their versions of clinical trials, so it's really quite clear the FDA agreed to essentially the same changes, but they, or the NIH don't change the record, it's up to the company.
Of course we'll never know for certain, such tales are never told. I would think that the DSMB could have called this to the regulators attention, as well as the fact that PFS wouldn't work as a goal, but again, they rarely stop a trial early for efficacy, though occasionally it's done. One of the chemo's I was on, Gleevec, is one of the rare cases when a trial was stopped early because just the form of leukemia I was being treated for was miraculously saving people, as long as they stayed on it. At the time it was approved I noticed it and indicated I thought it to be a perfect drug for the developer as it worked, but only as long as you took it.
Gary
