Northwest Biotherapeutics Announces Data Lock of Phase III Trial 05 OCT 2020 FOR IMMEDIATE RELEASE
CONTACTS Dave Innes 804-513-4758 dinnes@nwbio.com
Les Goldman 240-234-0059 lgoldman@nwbio.com
BETHESDA, Md., October 5, 2020 – Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today announced that the database for the Phase III trial of DCVax®-L for Gliobastoma has been locked.
With the database now locked, the independent service firms managing the Clinical Trial are arranging for the independent statisticians to have access to the unblinded raw data from the Trial. Neither the Company nor any party other than the independent statisticians will have access to any unblinded data at this stage.
The statisticians will proceed as quickly as possible with analyses of the raw data and prepare summaries of the Trial results for review by the Company, the Principal Investigator, the Steering Committee of the Trial, the Scientific Advisory Board, and a panel of independent brain cancer experts, who will analyze the data with the statisticians in preparation for public announcement and scientific publication.
"We are excited to be so close to the finish line now, after such a long road" commented Linda Powers, the Company's CEO. "We are hopeful that DCVax®-L can become an important new treatment option for patients who urgently need more and better treatments for Glioblastoma brain cancer."
"We are grateful to the independent service firms and the clinical trial sites who have worked so hard to complete the data collection and confirmation during many months of COVID restrictions and challenges," Ms. Powers continued. "We are also very grateful to our shareholders for their patience and support, which has made all this possible."
How could the statisticians proceed with analyses of the raw data and prepare summaries of the Trial results without the final SAP? They couldn't. . . . and the Principal Investigator, the Steering Committee of the Trial, the Scientific Advisory Board, and a panel of independent brain cancer experts, who analyze the data with the statisticians in preparation for public announcement and scientific publication would not let them change SAP after all this is done . . . and even if NWBO tried to do that do you think they would remain silent. These panels, boards and committees are put in place to ensure nothing untort/nefarious like data dredging happens. You're totally delusional if you think that could happen for even a microsecond. We have been through all the with you over and over and over for months now but it is like arguing with a wall.