NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

On IMGN the company worked with the FDA to design a trial that would quickly prove the benefit to the subset, certainly it's delaying the approval of the drug, and costing more, but not nearly what it would if a much larger trial was determined necessary. IMGN did work with the FDA and that's what was agreed on. Frankly I believe the FDA is becoming more dynamic and if the decision needed to be made today, I believe they would have approved the drug with a more limited label.

IMGN's case was no where near as strong as what NWBO's case will be if even as already has been reported, the median for the Top 100 is near 5 years. I believe that median will have grown to around 70 months and 70 patients or more will be shown to have exceeded 5 years of life after the initiation of treatment. I believe that will get the approval even if something else the FDA put in place is missed.

Gary