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Re: Doc logic post# 213915

Sunday, 02/10/2019 10:42:11 PM

Sunday, February 10, 2019 10:42:11 PM

Post# of 700594

I understand the limitations of this comparison but it's what we have to work with coupled with the fact that all patients past the hold were enrolled into treatment arm only:).



We don’t know that is a fact and LG told Ike that was not the case. So for now, I think calling it a “fact” is incorrect.

I do want to point out that I had done a very detailed “mathy-type” analysis BEFORE the SNO data came out based on all that chart work we all did where I had predicted that 28.1 of all the patients would live to at least 36 months. I don’t even know how that came out of my head (desperation?), and I have to look back at it because I usually forget how I even did it.

Still.. I did do it.

And I’d like to point out that when I did those numbers, I used the methylated and unmethylated patient data from the 3/17 to calculate what would happen to all the patients that had NOT yet been in the trial 36 months. That means that although the original 38 patients for which the methylation status was not available for were part of those first 182 patients, I ONLY used the figures presented for meth minus and meth plus to calculate the attrition rate as it would apply to the remaining 149 patients (331 - 182 = 149) for which the methylation status was known for.

And as we know now from SNO, I was pretty close in predicting that number. BWells (Floatserve on i-hub) did an excellent job of presenting that data and then taking it even further in this blog and I’ll post the link to it here rather than go find my own post.

https://seekingalpha.com/instablog/49123839-bwells18/5234734-recently-released-interim-data-northwest-biotherapeutics-dcvax-l-hints-upcoming-blockbuster

You’ll notice as you near the end of his blog that he suspected that prediction would be even better because we all thought those final 31 patients were on treatment only.

It seems that the last 31 patients all received DCVax-L instead of control (the trial was halted at 300 patients with a randomization of 2:1 for treatment to control, but the final percent of patients who received treatment was 70% instead of 66.7%) The journal notes that there 232 treatment patients and only 99 control patients, when with an exact 2:1 randomization on 331 patients would have yielded 110 control patients. When the trial was resized to be 348 patients, it was intended that there would be 232 treatment and 116 control patients. After the company indicated there were only 331 patients enrolled in the main arm of the trial, most thought the breakdown would be something like 221 treatment and 110 control. Instead, there were just as many 232 treatment patients as they had originally intended, yet there were 17 fewer control patients. We know there were 300 patients enrolled by August 2015, when a screening halt was implemented - and that 31 patients were enrolled after this point. It seems logical then, that the first 300 were randomized 2:1, with 201 to treatment, 99 to control. The additional 31 patients were then all randomized to treatment. The reasons for why this was done are still unknown.



But hey, the prediction turned out instead to be very accurate.
It was not better.
That’s not to say 28.2% is not fantastic. But it was dead on.

So… if those final 31 patients all had been put on treatment from the beginning, then I believe that percentage would have been made even better by the remaining 149 patients. Instead, the data for the final 149 patients performed almost exactly as the first 144 meth plus and meth minus patients did. Therefore, there is some logic to the idea that for whatever reason, those 31 additional treatment patients were sprinkled throughout the trial, and not just at the end. It's weird... I agree. The numbers made SOO much sense. But LG insists that it is not the case, and when I look at it like this, I have to agree.
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