Replies to post #16950 on NorthWest Biotherapeutics Inc (NWBO)

[inveterate]

Had exactly the same thought. It seems unconscionable that they would not give the treatment to all patients at this point.

[austinmediainc]

At the risk of sounding negative, here it goes. Who said that it increases OS by 12 months? Who said that the typical OS for this sub group is only 7-10 months? Les Goldman? NWBO? This wasn't part of the blinded trial and thus these comments by NWBO are a little suspect? People like to see study data backing up what they say.

Pyr said that on a positive note at least everything is on the table now. I disagree. We are still missing enrollment data which will make a huge difference in estimating completion of enrollment and events.

My opinion, long term = good and the short term = bad. With Phase 3 being pushed out until I would guess 2016 we will be left having to raise and dilute. The only thing that can save us IMO is German revenue surprising to the upside and or Direct Phase I data and quick moving Phase II.

[Doktornolittle]

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!

[RRRichmond]

BSB- These are not "random" patients. These are among the patients with the lowest chance of survival. They are all still progressing post SOC. Their OS is 7 months! DCVax-L has more than doubled their expected survival. Your point is well taken. We need an AA as soon as possible.

[sentiment_stocks]

BSB - I don't think the 55 patients could be considered "random" as they were, by their very condition (rapid progressors) segregated from the trial group. (sorry, see this has already been covered :) )

And as you have noted, their life expectancy is sadly even worse than the rest, the rest considered terrible in and of itself.

With a life expectancy of only 7 to 10 months, this "information arm" is demonstrating at least a doubling of their LE.

I would like to know a little more data such as how many of them are still alive and when their treatment began. Is this OS a predicted number based on powering, or is it the actual number? It seems there is a possibility that some of these people may live even longer because this is still the information to date on this arm. Whether or not that's the case, this is still a window to what's happening in the blinded part of the trial.

It would be nice to hear the breakdown data for these 55, though. Perhaps Linda will give that on Wednesday.

Overall, I'm glad we're no longer in the dark on L. And it sounds as if rapid progressors can expect a doubled life expectancy; and one might think that the non-rapid progressors (if you can call them that) can expect at least the same.

[foxhound02]

They are not by definition a random group, that is where you are wrong. I am with you that this is very good news, but it is just not how drugs are approved.