You can put me on the list ManiB for remaining in support of management if topline is not released before ASCO. I have said this mulitple times, but let me reiterate yet again. NMBO Management was crystal clear at the ASM that they were not and could not commit to having Topline released before ASCO. It is complicated multi-step process where they have to wait for responses for external organizations which is beyond their direct control. Here it is again from Ike's minutes:
NWBO 2018 Annual Shareholders Meeting Part 2
Question 3: Will NWBO unblind data prior to ASCO?
Answer (LP): "ASCO is certainly a great venue and it's been great for us when the timing has worked out, to be able to, as we did last year we had just announced the first interim data from our phase III trial, three days before ASCO, that just happened to work out beautifully on the timing. And a few years before that we had unveiled our initial DC Vax-Direct data. So we agree with you that its great when that works. I can't answer your specific question about what is going to be the exact timing of unblinding. What I can tell you is what we said in our press release on November 19th, which was right after the SNO conference and right after that we had announced the updated data from the clinical trial. And we said, here are the steps we have to go through in order to get to unblinding and then what we would do with the unblinded data. And you can look at what those stages are and you can read what we said that each of those stages is a multi-month process. And so you can figure the arithmetic. The first stage, as we said, we have to get the Statistical Analysis Plan developed and then submit it to regulators, and approved by regulators. That doesn't sound like much but it is a ginormous exercise. We are working with teams of experts. Neurosurgeons, neuro-oncologists, radiologists, regulatory advisors, statisticians. All of these advisors in a big team, which is the right way to do it, and there's a lot of complexity, to say the least, about the statistical analysis plan and the statistics that you put in. There's no one way to do it. If you read all the literature, and there's no single cookie-cutter 'this is how you analyze a dataset from a phase III trial, bum, bum, bum.' There's a lot of decisions and choices to be made and stitched together into a coherent plan. You can perhaps understand from the description I just gave you, which I don't think rises to material by itself, description of what goes into the process, why we say that each stages is a multi-month process. Because you go through that process with two-dozen experts, and then you go through the process again in regulatory approval of that statistical analysis plan. And remember, we're in four separate countries with four separate regulators. Which, yes, it is more complex and takes longer, but also means we have multiple chances to win. So it's worth, and we believe very strongly it's worth the extra effort and expense and time and so forth. So I know it's really frustrating.
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."
Men who are occupied in the restoration of health to other men, by the joint exertion of skill and humanity, are above all the great of the earth. They even partake of divinity, since to preserve and renew is almost as noble as to create.
