I was thinking it would be a good idea to re-post this part of the Stock Holders meeting. I feel its time to get excited as this week brings us to the middle of May and they weather is going to turn this Wednesday in the Chicago Area. Starting Wed 60's moving to the 70's for the rest of the week. Time to get excited about the weather and Our Little Diamond in the Rough.
So Let's Roll::::::::::::::::::::::::::::::::::::
And so, I wanted to just go through with you now where do we stand today and what do we believe will be the timelines to the remaining steps for announcing the data. Based on where we stand today, with the remaining queries, the remaining confirmations to be done with the hospitals, which we are assuming we will be able to do at least some work with during May, we anticipate that we will reach datalock by approximately the end of May.
“Additionally during this time, we’ve been working on making the data collection as comprehensive as we can. For example, in regard to certain genetic analyses, one that folks have asked us a lot about, I mean everybody knows we’ve been gathering the data on MGMT methylation status. Another genetic measure that folks have asked us quite a bit whether we will be including is IDH mutation status. There have been challenges because of a lot of the bio samples that we’ve collected we collected years ago in the trial. However, I’m happy to say that we have identified a method that we believe will enable us to include the IDH mutation status that effort is underway at present it looks like it will be doable even on bio samples from years ago. And it looks like it will be doable in the same timeframe as the anticipated datalock. So, we’re very happy about that and I’m happy to answer that question that a lot of people have had. The IDH mutation status was a completely unknown factor when our trial started and throughout much of the trial period. But in recent years has come to be recognized as very important in Glioblastoma. So we are continuing with the data collection and anticipate that the datalock will be approximately at the end of May.
“The steps that happen after that, there’s been a bit of confusion, folks have asked questions about how does the process work? What will happen at datalock, as soon as we have datalock the independent statisticians, we are not doing any of the calculations or analyses. They’re all being done by independent statisticians. They will gain access to the clinical trial database. Meaning they will have then access to all of the raw data and they will start doing all the calculations that everybody wants to see. They’ll calculate the median survival and the percent of survival at various time points and all of those various calculations. They will also do a lot of statistical calculations, t-values, hazard ratios, confidence intervals, etc. They will develop graphs and tables, all of the work that will take the raw data points and present them in a way that tells us the results. The clinical outcomes from this trial. That work will take several weeks. We anticipate that work will be taking place in June and as soon as the work by the statisticians is done and delivered to the company, that’s when we the company will become unblinded.
“We will not become unblinded at the time of datalock when the statisticians gain access to the database full of raw datapoints. We will become unblinded when the results of the statisticians, all their calculations and arithmetic gets delivered to us. Then as a final step we will, of course, consult with all of our medical experts. The steering committee of the Phase III trial, the Scientific Advisory Board, etc. And gather any questions or comments that those experts may have and make sure that those are addressed in preparing the information for public presentation. And as soon as that process with the medical experts is done, we will be announcing the results.
“I know the process has gone longer than many would like. We believe that having the process go longer and allowing the dataset to mature more has allowed a stronger and fuller and clearer picture of the capabilities of the DCVAX treatment to become visible, to become clear. Similarly, we think that the careful process that we’ve gone through, which was lengthy, last year developing the statistical analysis plan, and now the data collection and confirmation and cross-checking will give us the most solid basis for looking at the results. This is a very important trial. It’s one of the most important trials in the Glioblastoma space. One of the largest and one of the last Phase III ones to read out. So we felt that was very much in the best interests of the patients, the shareholders, and the company. But, I can assure you, management and the board are every bit as anxious and excited to get to the stage of unblinding and see those results. And we’re really happy to be able to give you this timeline today, this guidance, this visibility. Of course, nothing involving the future is certain. Things, we could hit unexpected bumps in the road. As I said, in mid-February we had no idea what would happen just weeks later and hopefully not some kind of change like that will happen, but we think the finish line is in sight now and we’re excited to be able to lay out this guidance for you. If the guidance changes significantly, we will find a way to announce that or update the guidance. And that’s basically what we wanted to convey and we hope that everyone’s as excited as we are. “
End meeting 13:31
