Replies to post #155596 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Here are Barcode’s notes from the meeting. The most interesting note is at the end of the posts below.

Sunday, January 21, 2018 8:39:16 PM
Re: None Post # of 155597
LP on the paper to be published:

When we made the announcement at ASCO, that was the beginning of the publication pathway. If you're familiar with top-tier scientific journals, it's not unusual for it to take 6-7-8-9 months. What I can tell you is that we worked on it the whole summer, including together with the doctors who are the investigators in the trial. Some 65 doctors all wanted to be co-authors on the paper, and we had to work through the process with all of them, and all of them reviewing the manuscript. The manuscript was only actually submitted in the fall, so we're only a couple of months into that process. We feel good about the process, but we don't control the timeline of the process. We're just as anxious as you are for the damn thing to get out, but we have to be patient.

This paper is about the interim blinded data. What we don't know, and what we're in fact not allowed to know, is the unblinded data. We can only see the aggregate total data from all the patients in the trial. We don't know the difference between the patients who got the DCVax to start with, which was 2/3 of the patients, or the patients who got a placebo to start with. The other things that's really important to know, is that the way our trial was designed, is that a patient would get assigned to a treatment group at the beginning, either SOC + DCVax or SOC + placebo. But then, when they had tumor recurrence, progression, everybody was allowed to get DCVax after that, and everybody still stayed blinded. We don't know, that patients don't know, the doctors don't know, what was in the syringe before their tumor progression. After progression, then we know everybody can get DCVax, and as we've reported publicly, nearly 90% of patients have now gotten DCVax, either initially, or after the crossover. So, the data is relevant and interesting to look at because basically 90% of the patients in the trial have gotten DCVax. So that's how we can write a publication about it.

We can't talk about the paper or present it at conferences. If we talk about it, a journal will not publish it. (Les) - We did say some things at ASCO that relate to some of the metrics of what Linda just described, and that is public information.
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NorthWest Biotherapeutics Inc. (NWBO)
barcode27 Member Profile barcode27 Sunday, January 21, 2018 7:36:15 PM
Re: None Post # of 155597
LP on the long tail:

The 233 OS events is not an automatic trigger, it's a floor, and we wouldn't unblind before that. But there's nothing that says we would automatically stop then. What we do is, we look, and all we're allowed to see is blinded data, so we're looking at aggregate blinded data. In immunotherapy, the big focus is the so-called long tail of the survival curve. That is the home run. And what it means to have the long tail, is that the survival steps down, and when people continue to live, the tail goes way out here to the right. If a treatment achieves a long tail, that's the home run. I mean, part of it is the slope of the graph, that's great too. But the big home run is the long tail. And you're seeing that being talked about with all of these therapies... with checkpoint inhibitors, everyone is super-excited because something like anywhere from 12 to 20% of the patients who respond in the first place are in a long tail and go for a couple of years. What people don't generally clarify is that even in the best case of cancers like melanoma where you're talking about a 25% response rate, you're talking about 25% of the 25%, talking about like 5% of the total participants in the trial. If some treatment were to come along and have 20 to 25% of the total patients in the trial, that would be considered a very large tail, and the question is how big and how long. That's what we want to see, and that's what you as shareholders should want to see. We share your anxiousness like it's Christmas morning. But when we stop the trial and unblind, the data collection for the purposes of the trial stops. After that, we will never know the full extent of the long tail. The long tail is the key focus.
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barcode27 Member Profile barcode27 Sunday, January 21, 2018 7:06:55 PM
Re: Poor Man - post# 154832 Post # of 155597
And Linda's additional follow-up on this topic (Cognate):

We've been the beneficiary of going for months and even years without paying for work being done. None of our other service providers would do that. Our CRO that manages the trial, if we pay them more than 10 days late for one month, they'll stop the trial. So, we've been the beneficiary of all of our products being made when we need them, and long long periods of time without paying the bills at all, then when we did pay, we paid in partly in stock and partly in cash, then we took that stock back again (laugh), with the NASDAQ settlement, and we had them write off big swaths of the bill. We have not been able to achieve any such treatment from any other service provider from all of the service providers we use.
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barcode27 Member Profile barcode27 Sunday, January 21, 2018 5:52:47 PM
Re: laser777 post# 154792 Post # of 155597
Yes, pretty much verbatim. Note that she went through the usual "forward looking statements" disclaimer before the Q&A started.
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barcode27 Member Profile barcode27 Sunday, January 21, 2018 5:00:05 PM
Re: rogers5729 post# 154755 Post # of 155597
Per LP at the meeting in response to a question regarding when they would stop the trial:

I can't spell out a formula for you. We do periodic data collections. When we do a data collection, it's about a 3 month process to collect an update. The independent CRO sends physical staff to all of the sites. We have some 80 sites in this trial. A breathing, human person looks at the files at each hospital and looks at the numbers and compares them to the central database. The central database is kept by an independent data company that's separate from the CRO. And, by the way, the company (NWBO) doesn't do any of this. That process generates what are called queries. Anything where a piece of data is missing or inconsistent, is a query. A data collection process can generate several thousand queries. All of them have to be resolved. Only then do you have a clean data set from the collection. Once you have a clean collection, then it goes to the independent statisticians who then tabulate it. So you have the CRO making the in person visits, you have the queries getting resolved and the independent data company holding the clean data set, and you have the independent statisticians tabulating it. It takes about three months to do that process. We have done it once each for the last three years. We have not made any announcements about the spring of this year, but, it would be a, uh, reasonable thought that there might be a similar cycle in the spring of this year. And it would be the same process, would take three months or so. As we reported in ASCO last year, a huge number of patients, way more than expected, were still alive. We have to weigh that... how much of an additional home run would we get if we continue vs. going with what we have now.