NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

I agree and disagree.

On the key point, yes, they may have gone back and forth and it may have been key to making the change that NWBO assert that PFS would be confounded as the trial ran, absent the change, whether absolutely true or not, I don’t think it is necessarily certain, but they could likely make a very strong case for why they believed so, probably, ironically, borrowing some arguments from the fudsters. That would be fun!

The selection of OS, ongoing survival, is a huge and determinative ultimate measure and change, no doubt about that fact. It is a certainty. Virtually all the other measures are just proxies for it. What NWBO management did, well, it’s like coming onto the field, bases loaded, down by 1, and bottom of the 9th - you point to the right field and say, “I am going to hit it out of the park, right there.” And if you do that, and even if you don’t hit it out “right there” (‘cause that’s just braggadocio) the game is over. That’s how I see it.

I don’t think there is uncertainty from the FDA whether OS is a good or appropriate measure for a successful trial, either scientifically or practically. I don’t buy that at all. I think some people are confused because they think “different measure” means uncertainty. I do not think that is the case with this measure. Because the other measures are proxies for this one, it is only more certain clarity, not in fact, a truly different measure. The other measures may, in fact, not even be good proxies, we’ve learned.

Other posters, obviously, and we know who they are, they will say it’s horrible, no good, bad and a disaster, no matter what the circumstances. Mainly they will say this because they are scared it will work, and stirring up noise, distraction, fear and uncertainty works in their favor. But it is not a permanent solution to the problem such posters face, and that is that they are not really making any real sense. It’s all just distraction and noise. If the results are what the company says, those posters will again, as has happened time after time after time, on issues that actually matter (not the noise), be proven dead wrong.