NorthWest Biotherapeutics Inc (NWBO)

[Pyrrhonian]

Wow, that's something afford. Condolences.

I'm not saying that at all. I was accused on this board of trying to scare patients and dissuade them from entering the trial by one disturbed individual. I know full well the interest in this trial is exceptionally high and will continue to be. But if we're going to give Direct as critical an examination as possible (because it is basically half of NWBO's pipeline), then as more data are revealed we have to go over it with a fine toothed comb and decide how it will help or hurt the investigational therapy's chances of garnering eventual FDA approval.

So far no ORR is one strike against it. And now a grade 4 tox has shown up in an "amped down" treatment regimen. As I keep saying over and over, that doesn't mean they can't now get approval (and it certainly doesn't mean inoperable cancer patients should stay away), but it does mean the "risk" side to the all important benefit:risk ratio has just gone up, demanding that the benefit side be that much higher to counter it.

No ORR at this point deep in the regimen is not a good sign and predicts a less effective product than CI and others vying for the same space. And when they ramp up the dosing, injecting 3x the lesions with more frequent injects at the most potent dose level, isn't it logical to conclude more grade 4 SAEs will show up? Of course it is. This discussion has nothing at all to do with scaring patients or patient interest in the trial--it has everything to do with the bar to eventual approval which has everything to do with an accurate valuation of NWBO.

Now you may say, hey but all of these _____DEAD PEOPLE_____ are ALIVE. But you don't know any of them or their prognosis! They're not even all stage IV patients. Read the criteria over again. You need a detailed case report on every one of them to know their life expectancy. You just will never have those data. You can only guess. Unless they enroll a concurrent control group, preferably placebo controlled. Then you can make a survival claim. Even if all of the patients live past two years the market won't care. In small Ph I trials researchers often pick the best from the bunch to give their tx the best shot with the least negative extrinsic variables to contend with as possible. Just why do you think most of the patients in IMUC's Ph I for ND-GBM lived past FIVE YEARS? And what happened in the randomized Ph II? I'm telling you no one, not the health community or the market is going to care about "encouraging survival" from a single arm study.

Direct data will move the pps when a) they can show ORR, or b) they can show a survival benefit in a randomized trial. Until then it's good for maybe $50mm in "good faith" market cap and will stay that way.