NorthWest Biotherapeutics Inc (NWBO)

[Rkmatters]

Just so you know when I state "open" patients, I do not mean Rapids. I mean open study patients for the nGBM open randomized study now open "information".

Company PRed about 33 in total at the start of Ph III.

If 17 at Overlook are open nGBM patients.
Ph II Blinded study was confirmed to be at 11 near the end of 2008. That leaves 5 unaccounted ones will be part of the open trial. I see those 5 being randomized into the open arm.
The more of those numbers are open the better the phii trial is going on enrollment as of 2012 in my opinion.

If it is 22, open nGBM from the Germany data only 14 will be vaccine like patients. (The control ones safety data would not be given to Germany.)

Now, as of 2012, Germany had received safety data on 73 ph III patients (overall open + blind study). If only 22 are open (again those randomized to SoC would be 7 control dropped - no safety on SOC patients) around 2/3 only would contributes to safety data on the entire Trial, so roughly 14 or 22. That leaves about 60 left from the Ph III blinded portion study to account for with enrollment into safety. On the blind portion of the study, placebo patient safety data will go to Germany with the group.

The rapids compassionate arm started in May 2008. Any pulled from the study, would come from the blinded enrolled number of 11 enrolled patients. I see that they don't include rapid data in their safety. So drop 1/3, if 7 were true nGBM; 4 Rapids. Germany only gets the safety on GBM not Rapids, as Rapids were not part of German study.

73 safety overall- 14 open vaccine patients = 59 safety from blinded only.
59 - 7 from pre-suspension = 52 post enrolled.

52 enrolled by Mid-2012 (restart only nGBM patients).

Easily they could added another 75 patients. They PRed in 2013 that they'd average about 25+ a quarter (they deleted that PR so it will likely be less). But over 6 quarters even if it's 15 a quarter that's not bad. (My account removed Rapids.)

So 7 enrolled (pre suspension) + 52 (2011- 2012) and ? (Mid 2012-2013 ).

7 + 52+ ? (enrollment from mid-2012-December 2013) patients= #? of enrolled patients.

66 events from that total.