NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

2015: NWBO did their first data collection! (blinded)

Why would you do a first interim analysis for efficacy in the summer of 2015 when you did a first blinded data collection in 2015? (and they have done it once for the last four years)

Sunday, 01/21/18 05:00:05 PM

Linda Powers:

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.

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