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Re: Basin Street Blues post# 16950

Monday, 08/11/2014 10:58:24 AM

Monday, August 11, 2014 10:58:24 AM

Post# of 730431
I am a little confused BSB. It is not clear to me what to make of these 55. There can be more than one reason for early progression.

If the stats they state are accurate, then these results sound very good. But early pseudo-progressives would have great responses that could swing the mean positive much farther than poor response from the true early progressives swings it negative and I am not sure if the simple mean is the normal measure for PFS efficacy. I thought there was some downplaying of extreme good numbers. I don't remember the method used by the FDA. (is the median used? That would downplay the extreme positives if they are not at least half of the population. That sounds familiar.)

As for the belated concern about radiation damaging the immune system... this bodes well for immunotherapies down the road as it makes it more clear that the change from existing radiation and chemo to immunotherapies is going to be turbulent. Those old technologies, however good or bad, were not optimized or selected for use along with chemotherapies.

But what does this mean at this point? Why would this have not been part of early statistics, whether they knew the underlying mechanism or not? Was there no radiation in the early data? Or just not enough data points... and the 40% that the radiation damages did not happen to be properly represented in that small group for the early studies? Without that knowledge, this post revelation does not make sense to me.

I remain very hopeful for DCVax-Direct. And I believe that the ability to target tumors directly and to not have to do surgery is such a wonderful possibility that I do not want to be negative about the company here. DCVax-Direct is much more valuable than DCVax-L. And it is more beautiful if I may use that word. So while early data remains promising, I remain very positive on NWBO. But I am not sure that the positive news today about L is not somewhat of a spin. If so, just hope the SP hangs in there until news on Direct becomes a focus. But this might be a short term problem.

Flipper is the progression vs pseudoprogression expert on this message board... and he is very smart. He catches things that I miss, and he sees things very clearly. And he is quiet this morning. Perhaps he is on a hike!
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