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Thursday, April 01, 2021 5:15:27 PM
The endpoints were altered BEFORE management unblinded the trial, which took place on 10/4/20.
ONE
PR: February 6, 2017
The Company remains blinded to all Trial data, and is only receiving and reporting updates on a blinded basis.
https://nwbio.com/nw-bio-announces-lifting-clinical-hold-dcvax-l-phase-iii-trial-fda-progression-free-survival-events-reached-overall-survival-events-not-yet-reached/
TWO
10K: December 31, 2017 (filed 4/17/17)
The patients, the physicians and the Company remain blinded as to which arm of the trial patients were in prior to crossover.
https://www.sec.gov/Archives/edgar/data/1072379/000114420418020971/tv491101_10k.htm
THREE
PR: May 29, 2018
The trial is ongoing while the data continue to mature, and the Company, the investigators and patients all remain blinded.
https://nwbio.com/nwbio-announces-scientific-publication-interim-survival-data-phase-3-trial-dcvax-l-glioblastoma-brain-cancer/
FOUR
PR: November 2018
The trial remains blinded, and all of the interim data are on a blinded basis (treatment arm and control arm combined). A total of 331 patients were enrolled in the trial (referred to as the “Intent to Treat” population or “ITT”). The last enrollments were in November 2015.
https://nwbio.com/updated-interim-data-from-phase-3-trial-of-dcvax-l-for-glioblastoma/
FIVE
10K: December 31, 2018 (filed 4/02/19)
The Company, the physicians and the patients remain blinded.
https://www.sec.gov/Archives/edgar/data/1072379/000114420419017803/tv517288_10k.htm
SIX
3rd Q: September 30, 2019 (filed 11/12/19)
The Company, the physicians and the patients remain blinded.
https://www.sec.gov/Archives/edgar/data/1072379/000110465919062726/tm1919565d1_10q.htm
SEVEN
10Q: 1st Quarter - March 31, 2020 (filed 6/24/2020)
The Company will remain blinded throughout this period and will not become unblinded until the independent statisticians deliver the initial results to the Company.
https://www.sec.gov/Archives/edgar/data/1072379/000110465920076154/tm2014603-1_10q.htm
EIGHT
PR: July 24, 2020
The Company will remain blinded throughout this period and will not become unblinded until the independent statisticians deliver the initial results to the Company.
https://nwbio.com/northwest-biotherapeutics-announces-completion-of-phase-3-trial-sites-databases/
NINE
10Q: 2nd Quarter: June 30, 2020 (filed on August 10, 2020)
The Company will remain blinded throughout this period and will not become unblinded until the independent statisticians deliver the initial results to the Company.
https://www.sec.gov/ix?doc=/Archives/edgar/data/1072379/000110465920092797/nwbo-20200630x10q.htm
TEN
PR: August 19, 2020
When Data Lock is reached, the independent statisticians will be given access to the unblinded dataset. The Company will remain blinded while the statisticians make the computations, converting the mass of raw data from the trial into formal tables and listings, and survival and progression measures, to report the trial results.
https://nwbio.com/nw-bio-announces-completion-of-further-data-gathering-for-phase-iii-trial/
NOTE:
Interestingly… the word “blinded” and any phrasing indicating the company is still blinded is no longer contained in the 10Q filed on January 15, 2021 for the 3rd Quarter Q.
https://www.sec.gov/ix?doc=/Archives/edgar/data/1072379/000110465921004396/nwbo-20200930x10q.htm
Nor does the company indicate they remain blinded in the recently released 2020 10K. The only references to "blinded" in the K are about the interim blinded data, and about how the patients were blinded to what treatment they received.
https://www.sec.gov/ix?doc=/Archives/edgar/data/1072379/000110465921044832/nwbo-20201231x10k.htm
Use Command F on your keyboard to quickly look for the word blind if you'd like to confirm.
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