NorthWest Biotherapeutics Inc (NWBO)

[CherryTree1]

Thanks for posting this.
I sent this email to them per their request at the end of the article:

Dear Ms Houser,

There are important allegations in your article that are wrong.
Namely when you state:

"When the terms of an analysis are defined after results have already been seen, it’s called a “post-hoc analysis,” and it’s a controversial way to assess a treatment’s efficacy. “The more analyses that are done post-hoc, the greater chance of finding results by chance — meaning that they are not true results"

Post-hoc analysis is defined as: "Post hoc in Latin means 'after this'. Simply put, a post-hoc analysis refers to a statistical analysis specified after a study has been concluded and the data collected. A post-hoc test is done to identify exactly which groups differ from each other. Therefore, such tests are also called multiple comparison tests." Post-hoc analysis is also at times called Data dredging -- sometimes referred to as data fishing -- is a data mining practice in which large data volumes are analyzed to find any possible relationships between the data. Data scientists can then form hypotheses about why these relationships exist. That did not happen here.

The analysis for the DCVAX-L Phase-3 trial was not "post-hoc" because the SAP (Statistical Analysis Plan) was updated and submitted before the trial data was unblinded. Updating the SAP is common before unblinding as stated here: "The plan should be reviewed and possibly updated as a result of the blind review of the data and should be finalized before breaking the blind." http://onbiostatistics.blogspot.com/2020/01/pre-specification-and-statistical.html

If you do you Due Diligence you will find your allegation that the SAP was done after data lock is completely incorrect If you review the their October 2020 NWBO press release:

https://nwbio.com/northwest-biotherapeutics-announces-data-lock-of-phase-iii-trial/

Northwest Biotherapeutics Announces Data Lock of Phase III Trial
05 OCT 2020
FOR IMMEDIATE RELEASE

CONTACTS
Dave Innes
804-513-4758
[e-mail]

Les Goldman
240-234-0059
[e-mail]

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. That could happen for even a microsecond. That is why these people were put in place.

I hope you find my comments and feedback helpful