Replies to post #544861 on NorthWest Biotherapeutics Inc (NWBO)

[Dr Bala]

A confounded post after the publication of great results in JAMA. Links please.

[hoffmann6383]

Bullshit. See: SAP.

[Doc logic]

HyGro,

“But that will play well with the FDA.”
-HyGro-

Agreed!; ). Best wishes.

[Roman516]

If you only would focus on the real facts and finally take note that DCVax-L works, and the OS data is valid. The JAMA report is valid, and they did their homework. The good news is that many doctors, scientist, and professionals agree as well.

[dstock07734]

HyGro,

Please put your comments on the JAMA website just like what that Matt guy did and see how it goes. The paper has been viewed more than forty thousand times. If your arguments are legit, it would serve for the public interest by preventing potential investors from falling into a trap.

https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847

[bas2020]

Stop with the BS nonsense!

[georgebailey]

Hygro that didn’t make sense.

[HyGro]

The statistically manipulated primary endpoint WON'T play well with the FDA (correction).
Double dosing treatment arm but compare to external trials that don't raises several issues.
Do you try to claim the "statistical manipulation" of the primary endpoint and try to claim no clinical advantage for DCVax-L double dosing vs. comparators that weren't screened for double dosing, .

[CherryTree1]

Completely false and misleading:

they are statistically manipulated the "new" primary endpoint.

and here is information on this topic from as far back as 2010 so this has been standard well accepted practice for years and years.
http://onbiostatistics.blogspot.com/2010/04/when-to-finalize-statistical-analysis.html

When to Finalize the Statistical Analysis Plan (SAP)?
"The statistical analysis plan may be written as a separate document to be completed after finalising the protocol. In this document, a more technical and detailed elaboration of the principal features stated in the protocol may be included. The plan may include detailed procedures for executing the statistical analysis of the primary and secondary variables and other data. The plan should be reviewed and possibly updated as a result of the blind review of the data (see 7.1 for definition) and should be finalised before breaking the blind. Formal records should be kept of when the statistical analysis plan was finalised as well as when the blind was subsequently broken.
If the blind review suggests changes to the principal features stated in the protocol, these should be documented in a protocol amendment. Otherwise, it will suffice to update the statistical analysis plan with the considerations suggested from the blind review. Only results from analyses envisaged in the protocol (including amendments) can be regarded as confirmatory."

This indicated that the ICH principal is followed as long as the statistical analysis plan is finalized or signed off prior to the study unblinding (or database lock if it is open label study). I believe this is the common practice in industry.

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop ICH guidelines.