Replies to post #439413 on NorthWest Biotherapeutics Inc (NWBO)

[meirluc]

Doc, perhaps 5-ALA was more extensively used to remove the GBM tumors of the last 108 patients and that may have been one of the reasons that at least 38.9% of that last cohort survived past 36 months whereas at most only 22.9% of the first 223 were as lucky. However, that most likely was not only the reason for almost doubling the percent of post 36 months survivors.

I tend to believe that NWBO intended to end up with a 2:1 ratio and were not so blatantly sloppy as to terminate this long trial with 2.34 times more Treatment than control patients. Over such a long enrollment period, NWBO had plenty of time to basically maintain a 2:1 ratio.

I therefore believe that for the first 300 patients a 2:1 ratio was maintained but most if not all of the last 32 patients were Treatment patients. There were about 83 Treatment patients and only 25 Control patients in that last group of 108 and that may be the main reason for the superior survival capacity of that last group.

Witness the German patient about to be enrolled during the late stages of the trial, who according to his wife was told by his physician that the trial was now closed but that he would most likely have only received the placebo. How did the physician know that unless he was told that the trial reached the maximum number of Treatment patients and/or if the trial were to continue, the rest of the patients were only going to receive the placebo. Perhaps at that point, it was ethical to inform the physicians that the trial was over but that their patients did not lose much because had the trial been extended, they would have only received the placebo.

[sentiment_stocks]

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.