NorthWest Biotherapeutics Inc (NWBO)

[AVII77]

No Biosect, you are wrong.
Read it
https://drive.google.com/file/d/0B9XkDkpumQZSNklfRHVoUU10OVk/view
The suit alleged failure at the 66 event interim, the triggering of which was announced in Dec 2013.
That interim (for efficacy) was never performed (despite being announced/pumped by NWBO as upcoming.)
https://www.nwbio.com/first-interim-analysis-of-nw-bios-phase-iii-gbm-trial-triggered-by-reaching-required-number-of-events/

The above PR was Dec 2013.
Subsequently they announced they never did an efficacy analysis at that interim.

Adam chided them claiming they were hiding the results.

The chair of the dsmb actually came out and said no efficacy interim was performed (referring to the one announced in the PR above in Dec 2013.

They then announced the trial was re-sized. The fact they were able to resize(amend) the trial confirmed (to me) that no efficacy interim was performed. Youcan't make a change like that after an efficacy interim.

However, the resizing did not change their plans to do a 60% efficacy interim. Instead of 60% of 110 events, that first interim was to be done at 60% of 248 events (the trial was resized targeting more events).

And it is that interim, the one expected in the summer of 2015 (coincident with the FDA clinical hold) where I am suggesting futility was observed on PFS.

And the company, nor the lawsuit, has said anything or denied anything about that interim.

Get your facts straight.