NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

Can I ask why the trial was flawed? Can you elaborate 1, 2, 3 etc?

Since you ask:

1 They ran a randomized trial, the concept is to show that those randomized to receive -L prior to progression did better than those randomized to placebo. That failed. They can spin this however they want, but the result is the trial as designed failed.

2) The trial had a primary endpoint of PFS but failed to measure it properly. By the time the trial was restarted in 2011 the issue of psPD was well known and methods were in place to avoid (or reduce) the problem caused by it. But in order to save time and money the trial used the design from 2006 when the the problem was not yet well known.

3) The trial had a key secondary of OS between the randomized arms Though they are failing to disclose there results, fairly obvious that failed badly. OS in early stage cancers is generally confounded by subsequent treatments, it is something the trial design has to account for,. But this design was for a small P2 and was repurposed as the P3.

4) The switch to ECAs was made after the efficacy IA had been performed Switching away from an endpoint after knowing the predefined endpoint failed is seriously bad.

5) Because the ECA was planned for, the trial was not designed in a way that allowed for a proper comparison to controls. No patient level data and not matched wrt characteristics.