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Friday, January 28, 2022 5:07:17 PM
lol...ok.
However, moving all the remaining control patients onto treatment would have taken place back in 2015. In making this move, wouldn't the trial data (and its ability to achieve a stat sig reading) have been somewhat comprised by lessening the number of control patients?
And why not just stop the trial, move them all over to treatment, and tell the company to file their BLA tout suite?
Surely it could be argued that this screening halt did no favors to Northwest, only making the hurdles they had to jump that much higher and much more numerous to get this trial to the end line six years after they supposedly made this move.
The dog can keep chasing the raccoon, but in this case, I think the dog is just chasing his tail.
I'm sorry to continue to disagree with those of you who think this is what's happening. It would be wonderful should this be the case, and I can assure you that I will be very surprised should this end up how it all really happened. And if it is, then boy, the FDA sure pulled a fast, and in my opinion, very negative move over on the company. With friends like that, well who needs enemies?
We'll see soon enough. I suspect, however, that there will be no mention in the journal of the screening halt having been done for reasons of efficacy. IMO, it was done to sort out what was happening with the treatment arm, and that the DMC may have seen these patients were eventing more rapidly and earlier than anticipated, and then their counterparts in the control arm. Then I think (conveniently to Furberg and his brother's company, IMO) that the DMC tried to get the trial stopped by first arguing this with the company (while the company remained blinded... the DMC is by protocol definition, not blinded), and when the company declined and opted to carry on (as was their right), Furberg took it to the FDA. And after that, his conflict of interest was discovered, putting some at the FDA perhaps on the wrong side of that poor decision, IMO. And if I'm anywhere near correct on how the events concerning the halt might have played out (and I'll admit, I could be wrong)... I frankly doubt that this would ever be publicly disclosed, especially if DCVax-L is approved.
However, moving all the remaining control patients onto treatment would have taken place back in 2015. In making this move, wouldn't the trial data (and its ability to achieve a stat sig reading) have been somewhat comprised by lessening the number of control patients?
And why not just stop the trial, move them all over to treatment, and tell the company to file their BLA tout suite?
Surely it could be argued that this screening halt did no favors to Northwest, only making the hurdles they had to jump that much higher and much more numerous to get this trial to the end line six years after they supposedly made this move.
The dog can keep chasing the raccoon, but in this case, I think the dog is just chasing his tail.
I'm sorry to continue to disagree with those of you who think this is what's happening. It would be wonderful should this be the case, and I can assure you that I will be very surprised should this end up how it all really happened. And if it is, then boy, the FDA sure pulled a fast, and in my opinion, very negative move over on the company. With friends like that, well who needs enemies?
We'll see soon enough. I suspect, however, that there will be no mention in the journal of the screening halt having been done for reasons of efficacy. IMO, it was done to sort out what was happening with the treatment arm, and that the DMC may have seen these patients were eventing more rapidly and earlier than anticipated, and then their counterparts in the control arm. Then I think (conveniently to Furberg and his brother's company, IMO) that the DMC tried to get the trial stopped by first arguing this with the company (while the company remained blinded... the DMC is by protocol definition, not blinded), and when the company declined and opted to carry on (as was their right), Furberg took it to the FDA. And after that, his conflict of interest was discovered, putting some at the FDA perhaps on the wrong side of that poor decision, IMO. And if I'm anywhere near correct on how the events concerning the halt might have played out (and I'll admit, I could be wrong)... I frankly doubt that this would ever be publicly disclosed, especially if DCVax-L is approved.
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