NorthWest Biotherapeutics Inc (NWBO)

[BlackDoggie]

In my opinion, that is the key. The journal article has been submitted and is awaiting/in process of publication.

For what it's worth, here's my read. Disclosure: I'm long here, but not for nearly as long as most of you. As a result, I don't have the frustrations that many of you, very understandably, suffer from at this point.

I believe the blinded data on OS is going to be used to ask for AA. Although I haven't found a case where this exact scenario has occurred, it's right in line with what Gottlieb has advocated for at the FDA - using early views on clinical endpoints (instead of surrogates) for the AA pathway. The article below has been discussed before, but it bears repeating at this juncture.

https://www.reuters.com/article/us-fda-hearing-testimony/fda-aims-to-approve-more-drugs-based-on-early-clinical-data-idUSKBN1DU2DS

In my opinion, peer-reviewed and journal-published data, even blinded, that strongly suggests significant improvements in clinical benefit would be nearly bulletproof for AA under this guidance. That's why the trial hasn't been locked and unblinded - IT IS NOW IT'S OWN CONFIRMATORY TRIAL. They won't unblind it this spring, and maybe not next spring... but they won't need to if all goes correctly. And that doesn't bother me one bit, because I think we'll all be very happy by then.

As for not giving updates, this becomes self-explanatory in my mind. They made it clear today (according to reports here) that they're not allowed to give any information on the journal article prior to publication. The last real update they gave was 9/1/2017, I believe. The journal article was submitted in the fall of 2017. Occam's Razor says that's not a coincidence. If the hopes of the company in terms of applying for AA rest with the journal publication, you simply don't jeopardize that by talking about any updates that may interrupt publication. What shareholders want short-term - more public information, in this case - isn't always best long-term, as painful as that can be in the moment.

I don't know when the journal will be published, but I suspect it will be soon. I believe that's why they pushed the ASM back as far as they did - hoping that it would be published by now. They won't ask for the share increase until the journal is published, because the "no" votes from shareholders would be a given. Most will be happy to oblige under better circumstances, which, given that management knows the content of the journal article, they know will be coming soon.

Also, keep in mind that AA can happen very, very quickly. A quick scan of FDA AA's for 2017 (through 6/30) showed that no drug approved under AA in 2017 to that date took more than 6 months from BLA for approval. One - Bavencio - took less than a month.

It would have been great to get more concrete news today, but objectively, there's nothing negative here. In fact, I'm quite happy that the journal article was submitted months ago. That means our expected wait is mostly over. I agree that the SP may slip in the short-term, but I think that getting out now would be a poor choice unless you're flipping for lunch money.