NorthWest Biotherapeutics Inc (NWBO)

[sentiment_stocks]

Hi BSB -

I’m with you on being long NWBO. I trade in and out of all my other stocks - but have not with NWBO since 11/20 when I traded out the first and only time. Pertaining to your questions, here’s my take:

66th, 88th and 110th event:

According to Sid (Akasidney) on his modeling of the trial - based on Pyrr’s figures - which I have reasons to believe are probably very accurate:

The 88th event would occur between July and August.

The 110th event would occur in December.

I'm not sure if Sid is still comfortable with this modeling proposal. Sid, if you’re out there, let us know if you still feel pretty good about it (and if I got anything wrong).


http://www.investorvillage.com/smbd.asp?mb=6543&mn=1457&pt=msg&mid=13923251


Pending vs. Outstanding:

On March 7, 2014, NWBO released their PR indicating that they’d received a “continue” on the Phase III L trial based on safety from the DMC (or the Data Safety Monitoring Board - DSMB). The PR also stated that the efficacy data was “pending”.

http://finance.yahoo.com/news/nw-bio-receives-recommendation-continue-130000641.html

Then on March 13, 2014 - their 8-K for that same PR came out for both that PR and the German HE press release. In the description of what the above PR contained, that section described the “efficacy data is still outstanding” - and the word used was no longer “pending”. I’m not sure but I think I may have noticed that first as I mentioned on Yahoo MB right away as I immediately noticed the double entendre. I just joked about it. But I think since then that we’ve all come to think (hope) it may have had more meaning than that. I’m sure those blinded at NWBO are only guessing, as are we. But as many more qualified than I have indicated, by going through all the data, etc., and the fact that we haven’t heard about the 88th event, it may, in fact be outstanding. (I’m going through all this for our latest prolific board member, Xena, too).

Recruiting Patients:

http://clinicaltrials.gov/ct2/show/study/NCT00045968?term=dcvax+l&rank=3&show_locs=Y#locn
According to the clinical trials site, they are still recruiting patients. One assumes they are still recruiting as they’ve opened the trials in Germany and the UK for that purpose. So I guess that answers that.

Why Would They Still Have to Recruit if the Results were so Good?

As others have indicated, to qualify, there is a long list of inclusion criteria. From what I’ve read on cancer compass, so many people that are diagnosed with GBM are rather at the “mercy” of the physician in charge of their care. If the surgeon does not reference the “L” trial, and the patient has a surgical removal of the tumor - and it’s not saved - well that’s that. They can’t enter the L trial because there is no tumor to make the vaccine. (Xena - L requires a tumor sample - Direct’s vaccine is taken directly from the blood).

It may also have to do with the locations too. Perhaps each location is alloted a certain number of patients and many have reached their allotment. That would allow some to still come from England and Germany and the more recent centers listed. However, the clinicaltrials list indicates they are ALL recruiting (except Georgetown, which is completed) - which I find interesting. We’ve discussed before why there are so many trial sites - such as the number in my area (Orange, Los Angeles and San Diego Counties) - I think: 6. Some of the OC ones are quite close to one another. Why have so many? Unless you are gearing up for something more than a trial :)

Why no update?

Pyrr goes into this in GREAT detail in his first? article on SA. Xena - Pyrr is Steven. I think Eval summed it up in his answer:

I suspect this might relate to keeping the integrity of the blinded trial, since some folks appear to be pretty good at coming to conclusions about how well the trial might be going if they know enough variables, such as the enrollment. As Pyrr recently mentioned .... "NWBO has already told us too much". Perhaps best to leave it at that and not try to dig too much further. I do think that Phase 3 trial on L is indeed still recruiting, with LP having recently indicated that she feels that this trial should be fully enrolled by the end of 2014.

And as Flip, Pyrr, and many others have said, no news on the 88th event is most likely - GOOD.

Could this be a bad sign that we’ve not heard about the 88th event?

Yes - if it’s happened, and they are hiding it from us because it’ll effect the stock price, that would be bad. Linda might go to jail for that though. So methinks she’s too smart to risk that. Otherwise, I can’t think of any other "bad sign". Maybe LTT will come up with something. ;)

Regarding the fact that NWBO isn't responding to your emails:

I’ve never had one email responded to. But I've also had Les answer all my calls. In fact, he answered my call tonight - but he’s at a tennis match and said he’ll call back. He may, or may not, but if not, I’ll just try tomorrow. The links on the website to clinical trials don’t work and that’s an easy fix. I emailed him and the pr people about that and it’s still not fixed. More importantly, the PR person at MD Anderson responded to my email yesterday and indicated he wants to have a “meaningful” conversation with me - if I’ll quit my “mass” emails to the MDA staff (I guess 6 people, including Les, is a mass email). So I spent yesterday composing a very thorough email of what I want answers to. I haven’t heard a “meaningful” response back yet. I’ll wait until tomorrow and if I don't hear back, then I’ll include the other 5 in my “mass” email. I sent an email to them yesterday about the CREW request. But that's another post to be made.

But, I wanted to check with Les to make sure he's okay with me continuing this correspondence with MDA - since there are a “few” here on the board that seem to have concerns about that.

NWBO is never going to respond to your questions about L in an email. First, they’d just be guessing - I’m sure an educated guess at that, but even so - to write something like that to one share holder will never happen. And I’m sure they must get boatloads of similar questions about it. I guess it would be nice if they had a form response so you didn’t feel ignored. But it would probably say something like, “we cannot answer questions about L at this time as it’s a blinded trial.” But please don’t equate them not answering you on these questions as signifying a problem. Try calling Les and asking him why we aren’t hearing about L. Perhaps that would make you feel more comfortable - and I understand that having such a large position in one stock merits feeling comfortable about it.

Talk about eat, drink and sleeping Northwest - wanna know something funny? I think the same day that the first direct results were pr’d, I had a screening procedure and had to be put to sleep like Michael Jackson with propofol. Anyhow, when I woke up, I shouted, “NWBO!” That’s what the anesthesiologist told me later. Then he wanted to know what stock it was. How funny is that?