NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

According to King's College researchers, the DCVax-L phase III trial is designed to analyze subtypes if that becomes necessary.

Virtually all trials are designed to analyze a variety subgroups/subtypes.

Still have to hit the primary else it matters for nought.

Take a look at Stimuvax. The P3 failed the primary, but a particular genetic type (that some thought should be the type most likely to respond) was stat sig. for O/S.

The FDA? Never had a decision as no BLA was every submitted.

As far as Flemming being somehow reasonable and open minded wrt trials that formally failed the primary endpoint but "common sense" said they should be approved. Check out Provenge in 2007.

The primary PFS was not stat sig (though not that bad a miss). The secondary, OS was P<.05 in 2 trials.

After the ODAC recommended an approval, it was Flemming who whent public with "it can not be approved" letter.

In short, trying to get approved on either a subset or a secondary with the primary ITT failing is unlikely.

They need to hit PFS in the full population, probably need OS trending very well, and still need a generous review.