NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

I thought this portion from the ASM was somewhat overlooked, so I decided to post it again with some highlighting.

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 [patient] 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. -- Linda Powers

Independent CRO = Contract research orginzation
Sites = Clinical Sites which are usually hospitals and Universities.
Central Data base = Basically an entire collection of 80 clinical site patient file copies.
Independent Data Company = Stores and Monitors the Central data base.
Data collection process = synthesis of local site files with central data base files. Can generate thousands of queries.
Clean clean data set collection = after all queries from the data collection process have been accounted for.
Independent statisticians = Tabulate statistical analysis of clean data set.