NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Instead,

"In parallel, and yes, people ask us all the time, 'are you at least doing things in parallel when you can?' Yes, we are. That thought has occurred to us. What we're doing in parallel is doing the final data collection. We had 82 sites in four countries with three languages. In order to do the final data collection a CRA Clinical Research Associate, employed by the independent CRO, the organization who is managing the trial independently, has to physically go to the sites, sit down with the trial database and the hospital records and compare them and find any piece of data that's missing or there's a discrepancy. The way the data gets captured in a clinical trial is in what's called a case report form. A case report form can be a hundred pages long. And you're looking for any piece of data that's either missing or there's a discrepancy. At every one of these 82 sites for every one of these 331 patients. And each one where there's a piece of data missing of there's a discrepancy, generates a query. And a query has to be resolved and the resolution has to be validated. The process can involve thousands of queries. That's just normal. That's what it takes to close out a dataset. And get to the point where we have a clean, full dataset that we can go to data-lock on.

So the big things that we are working toward and which we are doing in parallel, are moving toward the statistical analysis plan getting done and approved by regulators and moving towards data-lock. I hope that my description can help you see when we say it's a multi-month process, just making the physical visits at 82 sites and then resolving the thousands of queries you can understand why that's a multi-month process. So that's what we're in the middle of and we're as anxious as you are to see the results. That's the best I can tell you of the steps and the timeline." -- February 2, 2019