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Tuesday, January 17, 2017 12:27:10 PM
Do I understand you correctly, that you think there is space for speculation, that the update which is occurring before data lock could already be Top line data? Wouldn't that be unusual?
1. Yes, I think there is space for speculation. Some folks are speculating that the trial will be a success, and others .... not so much.
2. Do I think that "the update which is occurring before data lock could already be Top line data"? No. I was indicating in the post that you reference, that it is very unclear what any update might look like. The PR that the company issued includes:
08 DEC 2016
NW Bio Provides Update About Phase 3 Trial Of DCVax®-L for Newly Diagnosed Glioblastoma Multiforme Brain Cancer
Trial Enrolled 331 Patients;
Data “Events” Accumulating Towards Trial Endpoints
BETHESDA, Md., December 8, 2016 – Northwest Biotherapeutics (Nasdaq: NWBO) (“NW Bio” or the “Company”), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today provided an update about the Company’s Phase 3 trial of DCVax®-L for Glioblastoma multiforme (GBM) brain cancer (the “Trial”).
The Company announced that 331 of the planned 348 patients have been enrolled in the Trial, and that data “events” have been accumulating towards the endpoints of the Trial.
As noted in the profile of the Trial on www.clinicaltrials.gov, the Company had estimated that the numbers of “events” to reach the main endpoints of the Trial may be reached in November 2016. Following the end of the month last week, the Company requested updates from the external parties managing the Trial about the numbers of “events” (i.e., tumor recurrences or deaths).
Such updates typically take a couple of weeks, including quality control checking.
The Company hopes to receive this information and be able to make a further update announcement in approximately the next two weeks.
The Company remains blinded in regard to the Trial data and, as before, will only be receiving such updates on a blinded basis.
So, it appears that (as of Dec 8th) the company was anticipating to "be able to make a further update announcement in approximately the next two weeks."
But ... they did not indicate what kind of update that might be.
And they did indicate that any update they would receive would be on a blinded basis.
I am not 100% clear what the definition is of "topline results" is ... but wouldn't the trial results need to be unblinded (and data locked) ... in order to produce topline results?
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