NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

I believe it all comes down to how you define success. If 50 or more people lived beyond 5 years, many more beyond 4 years, and still far more beyond 3 years when the SOC indicated that roughly 15 people would have expected to last that long, I'd call it a success. On the other hand, if going into the trial some statistical figure was established based on progression, and the trial didn't meet that number you can call it a failure.

I believe the FDA has evolved enough to look beyond a goal set more than a decade ago, before pseudoprogression was know, and will be willing to adopt standards learned in the trial process to more properly judge the trial. Personally I wish the FDA would forget their statistical rules and look at the people who're still alive, or who started perhaps a decade or more ago and lived for years with a disease that kills most in 18 months or less, and simply see the benefits. I'm not a big believer in using statistics to make a decision where my eyes can simply tell me what the decision should be. All these people alive, or having lived longer than anticipated should be all anyone needs to see.

The FDA can find a way to say no, run additional trials based on what you've learned, it's not uncommon for the FDA to do so, but if they open their eyes, the answer should be a resounding yes.

Gary