NorthWest Biotherapeutics Inc (NWBO)

[sentiment_stocks]

You're wrong again, as usual.

They also did PFS for the Phase 2 trial and didn't seem to have an issue then and then proposed PFS for the primary endpoint for the P3 trial.

The Phase 2 was never unblinded as it was designated as the P3 trial in May 2012. The company wouldn't have known that there was the issue with pseudo progression which would eventually compromise PFS in the treatment arm at that time.

The Company also announced that the FDA has accepted an amendment of the clinical trial, which does not make any change in the treatment regimen, which leaves all data collected to date intact for use in the trial’s overall results, and which includes the following:

Designation as a Phase III trial
Expanded and enhanced statistical endpoint analyses
Addition of another cohort of patients which can potentially expand the application
of DCVax®-L, and which increases the trial to up to 300 patients
Addition of interim analyses for efficacy
A description of the trial protocol as amended will be available at www.clinicaltrials.gov.
https://nwbio.com/northwest-bio-provides-update-on-dcvax-l-brain-cancer-trial-2/