Not Brad:For some reason you and I came to the same conclusion at about the same time, namely datalock has occurred , maybe about 7/1 or before. They did put in 10 Q print that it would be done by 7/3.NWBO management consists of high integrity people.But what got confusing reading the tea leaves of the 10 q, and past pronouncements, is that datalock occurring does not necessarily mean datalock announced.Their wording in the Q gave them the flexibility to bypass a datalock announcment and go straight to a topline data announcement.But as we all know, it is of paragon importance that the TLD show statistical significance strong enough to cause the FDA to give DcVax L commercial approval for GBM. After that, the icing on the cake would be DC Vax Direct commercial approval for 13 solid tumors.
ae kusterer Wednesday, 07/22/20 11:22:53 AM Re: None 0 Post # 295855 of 295878 Thank you, Not Brad.Perhaps now the conundrum more understood.All this now makes the confidence expressed by others more understandable.
notbrad Wednesday, 07/22/20 10:41:25 AM Re: None 0 Post # 295849 of 295855 I went back to the June 2 announcement and tried to break it down and interpret it as follows. My comments are highlighted in red:
In light of the current status of the completion process, and the experience over recent months, the Company currently anticipates that the process (1) may be completed by about mid-June or shortly thereafter – i.e., within a couple of weeks after the Company’s anticipated schedule at the time of the Annual Meeting in April.
(1) what does process mean? Refer to previous paragraph – “The completion process includes final data collection, identification and resolution of queries, data checking and confirmation, and site sign-offs.
If some of the information that currently remains outstanding cannot be obtained by mid-June, the Company may consider proceeding with a “soft lock” of the data at that time, if arrangements can be made for the rest of the data to be included when it is obtained later. The Company plans to obtain advice from its regulatory counsel, its Scientific Advisory Board and the Steering Committee of the trial in regard to such possibilities. (This paragraph continues to refer to data collection and resolution of queries).
It is too early to determine what effect this update of the anticipated timing of data lock may have on the anticipated timing of the public announcement of data. There may be a similar update to the timing of the announcement of the data as to the timing of the data lock.
This sentence is key – it’s confusingly worded. I would read “timing of announcement of data” as announcement of topline data. I also interpret it as saying there will be another announcement IF there is delay in data lock. It does not mean that there will be an announcement of data lock. Since there has been no announcement, this implies data lock has already happened.
The steps that will take place after data lock remain the same as were outlined at the Company’s Annual Meeting. Initially following data lock, only the statisticians will be unblinded (i.e., will be given access to the database containing all of the raw data from the trial). The statisticians will need several weeks to carry out all the relevant analyses and calculations. Then the statisticians will deliver the results to the Company, and that is when the Company will become unblinded. The Company will then discuss the data with key advisors, such as its Scientific Advisory Board and the Steering Committee of the trial, and will address any comments or questions from its advisors as part of preparing the data for public announcement.
Here the company has given itself several weeks between data lock and top line announcement. So, if data lock happened towards the end of June or early July (we can assume data lock happened as anticipated since there was no announcement), then the company has several weeks to announce top line data. So then, how many weeks is several weeks? Perhaps 3-4 weeks at a minimum, and up to 6-8 weeks at a maximum. Which would mean that the company has anywhere from now until end of August to announce top line data.
They did not commit to announcing data lock. They committed to providing an update if data lock was further delayed. No announcement means no delay in data lock.
ae kusterer Wednesday, 07/22/20 10:27:04 AM Re: None 0 Post # 295844 of 295854
The 10 Q specifly states that datalock would be done by 7/3/20.If NWBO's material information dissemination to date is consistent with the Q, then datalock did happen by 7/3.They never said they had to notify us when it happened . They just said we will tell you sometime in the future when it had happened in the past.Capische?
The independent service firms are pressing to obtain the rest of the site completions and investigator sign-offs. The Company hopes they will be completed by approximately the end of next week. Accordingly, the Company is aiming to proceed with data lock at approximately the end of next week.
Dan88 Wednesday, 07/22/20 09:12:37 AM Re: None 0 Post # of 295838 Dave's response to one poster in this board:
Quote:
I am not sure why this is an issue. We have said for a long while that we will notify all at the same time when we have reached lock.
Hope that helps
Dave
end of Quote
I don't know why some here feel confused with regards to DL from Dave's response. From his response he clearly indicate the company will notify when DL WAS reached. It was completed, and he didn't promise the company would notify as soon as it happened.
So one way to notify us is a paragraph or a footnote in topline data news release, just mentioned when data lock had had happened.
As I have said all along it [DL] did happen, and next may indeed topline news.
WE ARE IN THE QUIET PERIOD! Buy shares as much as you can afford.
Overview
The Company is focused on developing personalized immune therapies for cancer. We have developed a platform technology, DCVax®, which uses activated dendritic cells to mobilize a patient's own immune system to attack their cancer.
Our lead product, DCVax®-L, is designed to treat solid tumor cancers that can be surgically removed. We are in the process of reaching completion on our 331-patient international Phase III trial of DCVax-L for newly diagnosed Glioblastome multiforme (GBM).
As previously reported, the Company is working with the contract research organization (CRO) who has managed the trial and a number of independent service firms to complete the data collection and confirmation, and reach data lock for the Phase III trial. All of the data collection and confirmation is done by the independent firms, with the Company in an oversight role.
As also previously reported, coronavirus-related difficulties have impacted most aspects of the process. Trial site personnel have been unavailable due to being reassigned to COVID-19 patient treatments or otherwise, and the limited site personnel have had to work under restrictions. Committee processes such as Institutional Review Boards and Ethics Committees have been, and continue to be, focused mainly on COVID-19 matters, with other matters significantly delayed. Regulatory processes have been similarly focused on COVID-19 matters and delayed on other matters. Firms such as the ones storing the Phase III trial tissue samples needed for certain final data, and the firms conducting the analytics for that final data (such as IDH mutation status), continue to have only limited operations. Even logistical matters such as the shipping of tissue slides have been, and continue to be, subjected to substantial restrictions and delays.
Despite these difficulties, the CRO has completed the final monitoring visits to the trial sites (including a number of them virtually), and has completed the collection of Case Report Form (CRF) data for all patients in the trial. The CRFs contain most, though not all, of the data required for analyzing the trial.
Since the Company’s prior updates, the CRO has also completed the Source Data Verification (SDV) for all of the data contained in the CRFs. Further, the CRO has completed the resolution of the many queries.
The independent service firms have also collected most of the additional data that is not contained in the CRFs, such as additional MRI scans and certain genetic information. The Company is consulting with its advisers to obtain their support for proceeding with initial data lock without waiting for these additional data, and then to include these additional data in the database when they are available.
The primary focus for reaching data lock now is obtaining the trial sites’ data locks. In order to reach overall data lock for the trial, each site’s data must be locked. Preparatory steps must be completed at each site so that the site is ready for sign-off, and then the lead investigator at the site must personally sign off on the data from that site. To that end, the lead investigator must undergo a brief training on the system, review the site data/CRFs and personally complete the confirmation and submit it.
Since the Company’s prior updates, the CRO and service firms have completed the preparatory steps for all but about ten of the sites to be ready for the investigator’s sign-off. Among the sites who had reached readiness for sign-off, about 33 sites are in varying stages of accomplishing their sign-offs and the rest of the sites have completed theirs.
The independent service firms are pressing to obtain the rest of the site completions and investigator sign-offs. The Company hopes they will be completed by approximately the end of next week. Accordingly, the Company is aiming to proceed with data lock at approximately the end of next week.
As previously reported, upon data lock the independent statisticians will be given access to the clinical trial database containing the raw data, and will undertake the applicable calculations and analyses. As previously reported, the Company will remain blinded until the statisticians have completed these calculations and analyses. That process is expected to take several weeks. The Company will then receive the initial results from the statisticians and become unblinded. Then the Company will consult with its Scientific Advisory Board, trial Steering Committee and expert advisors about the data, and address their questions and/or comments to prepare for announcement of the data.
The Company’s primary focus at present is on its DCVax-L program and completion of the Phase 3 trial of DCVax-L for Glioblastoma brain cancer. Our second product, DCVax®-Direct, is designed to treat inoperable solid tumors. A 40-patient Phase I trial has been completed, and included treatment of a diverse range of cancers. As resources permit, the Company is working on preparations for Phase II trials of DCVax-Direct including discussions with key institutions in regard to trial design and trial preparations. The Company has stopped the DCVax-Direct contract manufacturing preparation activities at present, while the trial design activities and preparations with the trial sites continue.
News 
Market Data 
Discover 
