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Hundreds of longs reading this blog:
As Etienne has said, for every one of us active bloggers, there are hundreds in the background reading what we write. That alone would give us quite a bit of power, and maybe enough money to do one of those Yahoo PR's or such, announcing the action.
If we really were to do this, should we start with a civil action, and then do the complaints to the SEC or FTC, or the other way around?
CLDX: Yes. I noticed. He keeps mentioning it, and saying it is a similar technology. Why would you push a product that is similar to the one that you are consistently saying could never work because it is fundamentally flawed. That makes no sense at all. That makes him more transparent, but not sure that is in the lawsuit.
We Could Sue.
Maybe we should. The problem right now is that I don't want to sell in the midst of this to pay for attorneys. If I wanted to sell right now, the money should go to Hodge or some other deserving person.
But we could start talking to firms to see how difficult it would be. We need to sort out the offensive or absurd stuff from the flatly libelous stuff. Condense it down for the attorneys.
I will try to get around to talking to some firms if nobody else does. I would start with the firms that have posted recently for lawsuits by investors against companies that misrepresented. But I would look at other sectors. I wouldn't trust any of them in this sector.
I learned recently that the Vikings used to eat those red mushrooms with white spots before going into battle. I have to find some of those for when this battle starts. But for now, I am just going to talk to some attorneys.
Or was it the white mushrooms with red spots on them? I better look that up.
German approval could be effective EU approval.
Working in electrical years ago, there were two important European approvals for components, (Circuit breakers, current monitors, UPS's, etc.). There was VDE (German) and CE (EU). The VDE approval was the technical safety approval and the CE "Mark" was primarily a trade approval, not a technical approval, as I understood it.
VDE approval was good enough for everybody in Europe. There wasn't a French approval, or an Italian approval... they didn't need it.
DCVax-L just got an effective VDE approval... sort of. They are now negotiating pricing and somebody said this pricing will set the price throughout Europe. So they are currently negotiating the business part of things... sort of like the CE mark.
Not sure drugs/therapies would behave similar to electrical components... but if they do, there may not need to be a bunch of trials in other countries in Europe.
Even if other countries require there own stamp on medical... how long would you spend sorting through the data with the German's already having approved it and your citizens travelling to Germany to get treatment?
If they can pick and choose fastrack options in different countries for Direct and DCVax-L:
I don't see any real difference between a full approval in Germany and what they have been granted. I could be wrong, but all I see is the marketing restriction, and I don't see that as significant. Others seem to agree.
Approval of DCVax-L in Germany is going to have a huge effect on the perception of Northwest worldwide; not just in Europe. The Germans are well respected everywhere.
We really don't know what the news will be on Direct come the end of this month, or in June at ASCO. It could be less than we are hoping. But if significant results are reported, then I would think that would also get a huge amount of attention world-wide. That could put Northwest in the position of being able to pick and choose fast-track clinicals world-wide. If that happens, then I hope they are able to negotiate some wiggle room in the clinical proto-calls as the clinicals progress. If you look at how long DCVax-L took to get to this point; and consider that they had to keep the protocol rigid for that entire period... at least once Phase III started... not being able to add any of the things they learned along the way... it is just sad.
Then look at Direct, which will be fast-tracked. But it is so new. It needs to continue to be in development... yet it needs fast approval. How do you do both? Some country needs to bend over backwards to get the trial, and offer this flexibility as part of the incentive. I think Japan might be that country.
I'm not sure Pyrrho. Is a sticky a good thing or a bad thing?
You really did become a moderator!
Don't let the power go to your head. They have done studies on that. It's automatic. Can you feel it?
Insurance Approval Huge!
I would think that the approval for insurance coverage would be a much more positive thing than the lack of the right to market it. Doesn't the insurance approval make it basically approved for Germans, period?
No Need to Market DCVax-L.
Smith underlined that the German decisions do not allow marketing of the therapy.
But this isn't like Zoloft or Viagra. And this is the day of the internet. Every physician will know that DCVax-L is one of their options. And every patient who looks on the internet will find DCVax-L very quickly. I would think.
Drug companies waste huge resources doing marketing. Here there is no need for marketing. The fact that they can't market it in Germany doesn't matter. IMO.
But Smith doesn't think the German's had access to the Phase 3 data. He knows these things, and he talks to Northwest a lot... so he is probably right.
But it doesn't make sense that Germany would make this decision so close to the DMC recommendation. It just doesn't make sense unless they got some kind of an indication that the phase 3 data looked good. IMO.
I really like Smith. And I bought a year membership to his stock advisory. (you can turn off automatic renewal in Paypal after you sign up if you want.) So... I am not criticizing Smith, at all.
Take Notes on any Bashers:
There will be the regulars, but I will take notes on all of them. Good future reference for investing. Divisive, dishonest people to be ignored. This is straightforward good news on a very large scale.
$15 on this news. $45 if early DMC. More after ASCO.
I really shouldn't guess because that is not my forte', but these are my honest guesses. For swamprat and others that are feeling bad because they sold shares recently, I say, buy them back. The loss is not that large at this point on the scale of things. This stock has not yet begun to rise! Seriously.
You sold stock that had a substantial downside risk. You would be buying back stock without such a risk and with enormous upside potential. Not a bad thing to do. Not a dumb thing to do. Don't think of it as a loss. The stock you sold is not the same stock you would be buying.
It is still heavily undervalued.
It was up almost this high just on news of Goldman's investing a week or so ago. This is nothing. The upside is enormous, but biotech always has a huge risk of absolute failure that keeps prices way down. There is no more risk of failure, period. I don't know where the stock should go on this news, but it isn't $8.
People were afraid of NW because IMUC's ICT107 phase 2 was so flat. That made their Phase 1 data look manipulated. It made sense to be wary that Northwest's phase 1 data could also be misleading. To bet heavily on NW meant assuming their Phase 1 data was more solid than IMUC's and to believe that it came down to evaluating personalities, etc.. Hard to do. (that and the fact that a phase 3 was approved on blinded phase 2 data).
This news puts all that doubt behind. In doing that; in validates Northwest Biotherapeutics itself, validating every project they have going to some degree. That means Prostate and Direct. Those projects are much larger than L. Removing risk of failure in biotech is absolutely huge. Reducing risk on these other projects is also large X huge projects.
I don't want to say how high I think it could go by the end of this month; by the end of July; by the end of this year.
Where are Anderson and GBP?
Even if L Only Got a US Continue, You Now Know What The End Will Be for the Trial.
And you know that financing to finish out L, in the unlikely event that it is necessary, will be easy to find. And the credibility gained here might mean a partner for Prostate any day. Sounded like they had people talking about it already.
And as rigid as the DMC has to be on Stats... any wiggle room has to lean now toward a recommendation of a halt on efficacy.
And Direct is now funded.
And the stands will now be filled at the football field that they have rented for ASCO.
Etc, Etc, Etc,
Hopefully Flipper Got into the Brandy!
It is unusual for him to not be online at this time. Hope all is well. And a thank you to Flipper for being so positive. I criticized that at times when I thought people could be caught off guard without considering all the possible negatives too... like someone playing musical samples... etc..
Thanks also to John, OU, and others that remained positive throughout.
I did give some nice positive thought in times of doubt recently!!!! Though at times I got quite concerned, and voiced it.
How Many Shorts Left? We will soon find out.
F-Stein's PR's probably let many shorts out of their dungeons over the last week, but I wonder how many remain. The are screwed.
I don't know how to get current shorts data. The last reading I can find is pretty old.
This could be an absolutely enormous short squeeze.
Murky??????!!!!!!!!! WTF!!!!
Well sell your stock to me then. I would gladly pay you $7 a share on Wednesday for all your shares today. Quite a premium! You have to think about it. It's probably all a big con job. Not too late to get out! Enron. IMUC. Phase 2 blinded. AF warned us all! Think about it!
Hodge. This can't hurt your situation.
The added credibility for Northwest, and the $ soon to come from Germany and investment should help Direct. They are almost at the end of the low patient volume portion. This will allow them to soon expand dramatically in their trials when they finish this 3rd dose level clinical stage.
Prayers to your wife. Hang in there! The cavalry is coming!
I just bought 10% more at $6.40!!!!!!!!!!!!
The world is asleep! Thank you!
It must be a daylight savings time issue.
Who sold me that stock?
I would have missed it for that reason, but I get up at 4:45AM these days since I am on the west coast and things start happening soon thereafter. So when I screwed up today, it was still only 5:45 when I got up.
I can't believe I just bought another 10%. That was the last of the money that I have available. I would have bought more.
Good Stuff John! NW More Affordable Again!
The article describes much better pricing for Tumor Storage at Northwest than at the other company listed.
"StoreMyTumor contracts with Penn to process and store the tissue.
So far, Sadaka said, about 600 people have used the service, which typically costs $4,000, plus $38 a month for storage."
"There is at least one other private tumor bank. HealthBank is run by Northwest Biotherapeutics, a publicly traded cancer immunotherapy company based in Bethesda, Md. It charges $2,000 for processing and a year of storage, plus $195 for each subsequent year (about $16 a month)."
4 Years at "Store My Tumor" => $4,456
4 Years at Northwest's "Health Bank" => $2,780
10 Years at "Store My Tumor" => $8,560
10 Years at Northwest's "Health Bank" => $3,920
The fact that Northwest is currently delivering this service at a much lower cost than a big player in the field gives credibility to their claims that they will be able to provide DCVax-L at 1/3 the cost of Provenge. In spite of their tiny size, Northwest Biotherapeutics is apparently a very well run organization.
I am seeing the ink blot PR differently now.
Maybe I will flip back to the other interpretation, but reading it for the 9th time... it just says there was a pass on safety and (at 88 events unstated) there will be a review of efficacy. That's all. Not even a big scheme to make it sound like an efficacy finding is currently pending on the 66 events.
But with info on Direct coming soon, and a PR about Germany likely coming even sooner, a simple pass on this part of the review process is just fine.
Are you sure that more than the safety committee is reviewing this and gives a recommendation this time around? You... being whoever believes an efficacy review is still coming. If so, keep talking me into it. I want to believe. I do want to believe! Of course if that is the case I want to believe that the continue means any such efficacy finding could no longer be futility.
Why Not Just Call it a Continue?
Because apparently it is not just a continue! A lot of people asked that question in their posts today, and I don't understand why.
They could have said... "It's not a halt for safety or futility". That might have been more clear, but but then they would have been talking in negatives.
The other thing being said is that there is still the possibility of a halt for futility. Apparently some people believe this because efficacy has not been fully evaluated.
If that is the case, then NW's PR is misleading. So, I believe that is not the case.
However, having worked through this a couple of times now, I do see the frustration with the wording. I am back peddling a little bit. I hope that wording was necessary. If there is a chance of a halt for positive efficacy, then how could they call it a continue at this point. Maybe just no good way to say it. But... I do see the reason for frustration. And if there is still a possibility of halt for positive efficacy, then is there still a chance of halt for futility? I read it as no, but... I see the frustration.
I don't understand why you are so upset about the PR. NW has a very small crew. Linda Powers' primary job has been financing these tremendously expensive trials. Another of her jobs is to not make any false statements.
This is a touchy time period where the company would probably rather not say anything to avoid saying the wrong thing. But investor pressure and or the massive short accumulation forced them to say whatever they could. This is all they could say. That seems straightforward to me.
If what was said turns out to be misleading, then that is another story. But I am not one bit uncomfortable with what was said, while you are obviously very upset about it. I don't get your point of view on this.
I've doubled my investment in the last 3 days.
Wish it had all been today... but still happy. Irrational pessimism abounds.
OS Powering Remains?
OS powering would take longer than PFS, right? While the subgroup complications might account for the delay, it might also be as simple as waiting for statistical significance for OS.
I couldn't find the posts earlier today about the need for OS to be ok / not negative. So this may be a repeat. If so, my apologies.
But wouldn't it make sense that they are just waiting for statistical significance on what is clearly positive OS data? If OS data was negative or iffy, they would not have announced a continue yet. But if it was positive, but did not yet meet powering, and PFS met the goal and powering already, then it would be unethical to wait until 88 events... if powering for OS is projected to be met well before 88 events.
Back in December, 110 events was projected to occur at the end of this year. That put's 88 events in June, possibly July. Depends on how much they were counting on Germany. But even in July. That is only 4 months away. If the continuation of efficacy analysis is for powering of OS, then the wait is expected to be significantly less than 4 months.
You can't just continue on PFS because you have to have scans done on all the patients. I guess you could as long as scans are scheduled often enough, but it makes more sense for OS.
But I don't think they can just go along day by day and see if powering is met yet for OS. I think that violates some aspect of statistical analysis. I think you have to pick a date in advance and evaluate on that date. Something less than 4 months is my guess. Depends on how close they are to having powering already.
Fuerstein is probably just trying to let the Shorts out of their predicament. I was wrong about volume, but that might be just foam on the beer. That my end soon and start forcing the stock to pop.
With such crp coming from Feurstein, I am starting to agree on how useful a go ahead in Germany would be. People would trust that implied interpretation of the situation by the Germans.
But who's going to sell?
Nasdaq lists the time to cover as 8 days with a daily volume of 547K shares. But what if nobody wants to sell?
Traders without an understanding of the pending possibilities might sell. Still, it will be interesting to see if the volume is above or below the 547K average.
Caught with their Shorts down and nowhere to go!
More big dogs in today forcing a short squeeze with the pending possibility of a halt for efficacy tomorrow. So every short will be forced to sell... maybe.
Normally when this pop happens, there will be sellers taking profits at whatever they believe the peak is, but who would sell now with the possibility of a halt for efficacy tomorrow? So this short squeeze is going to be huge!
Possiblity of a halt for efficacy tomorrow and possibility of a PR on Direct progress in 2 weeks if they did not get accepted to ASCO.
Note that ASCO rejection would not necessarily mean the data is not good enough, just not mature enough at the time they submitted, which was some time ago on the relevant scale. Acceptance would be a plus, but denial might be even bigger because they said they would then be in a position to share progress.
So the short term is very scary for the shorts, and the medium term is very scary... and the long term is a frkng nightmare.
Ahhhaaahhhhhaaaaahhhhhaaa!
Ahhhaaahhhhhaaaaahhhhhaaa!
Ahhhaaahhhhhaaaaahhhhhaaa!
Run ye shorts run! But there is nowhere to go!
Flipper: You know Germany is excluding pseudo-progression?
I thought you were speculating that to account for some missing 22 patients... but you know that is part of their trial design?
I think that's it OU.
Whether it was Diamond Jim's pleas or many similar pleas, I think that is it.
So... I don't know why people are talking about the 88 events at this point. We just know it's not a stop. They could tell us tomorrow that all of the subgroups or some of the subgroups are stopped for efficacy.
That releases pressure on the stock price and saves me and others the expense of buying cabbage for our ulcers... except Flipper.
Germany may wait till efficacy decision:
The continue would probably be enough to make Germany feel good about going forward, but what if a stop for efficacy would change their trial format or even just the paperwork?
As people speculated, Germany may have learned far more than we have about the trial data, but if not, they may want to wait the extra (week, month?) to make sure they know as much as possible.
Yhoo is Seeing this Very Positive:
Latest posts over on Yhoo are viewing this as a pass for safety while the review continues for efficacy. That makes sense to me.. and maybe that means that they can continue to collect data and possibly halt before 88 events.
It seems possible that due to the complexity of the trial that they simply aren't done yet reviewing efficacy, but have enough info to know it will not be a stop. Maybe it means the data is on the edge of a technical pass on efficacy... close enough that it would not be ethical to wait the 3 to 6 months for the next milestone, knowing that they will be over the hump in a few weeks.
This is very very good news... The big guys don't want to risk big $ with the minor chance of a stop. And now that minor possibile disaster is gone. The stock will pop, and the shorts will be squeezed! And we are not done yet!
If continue... then stop for safety and stop for futility are both ruled out, right?
Very glad to here that your wife got enrolled. You must have moved mountains as my understanding was that enrollment was extremely limited.
I was glad that John chimed in today with his note about your situation and the link to your website. I am just an investor and at times lose touch with the reality of this effort. That grounding is valuable.
What a great picture of your family. What a beautiful family, and how clear that the picture should not change.
Did your wife already get enrolled in Direct? I remember when you started on this blog, but I have been gone for a while.
Hang On! It's just a Shake and Bake!
Most of us are familiar with the infamous, but necessary "pump and dump". There appears to be the counter-part; the "Shake and Bake". Not sure exactly how or why (in contrast to the pump and dump which is survival of the biotech) but it seems to happen a lot. Lots of good possible explanations today, however.
Not this time boys! I'm not budging.
Could the DMC bypass NWBO for now?
In the DMC guidelines (that Flipper circulated recently) there is at least one statement about trying to keep the "Sponsor" out of the loop as much as possible to avoid poisoning the blind aspect of the trials.
I don't know how realistic the speculation is that there could be talk between the DMC, FDA, and European regulatory bodies, but if that is going on, couldn't it be without NWBO in the loop, at least till things get hammered out as well as possible?
If that is at all close to what is going on, then the PR people hired by NWBO would be the last to be informed of anything.
60 Day Deadline was Unrelated:
I dug up the article that stated a 60 day deadline for the IRC. It was not for an interim review exactly, and it wasn't for the drug I had mentioned. It was a very different situation which would confuse things further if I describe it. Never mind.
I couldn't find that info Austin.
I looked for exactly that info, (which review and how long was the wait) a few days ago when I ran into the article, but did not find that info.
What did I run across in that search was a description of the review guidelines that stated a 60 day deadline for the review. I thought they didn't ever have deadlines, but they did in that case.
Shorts walking down to get back in?
Before and just after the Goldman's announcement there was a high volume run-up followed by a very low volume, sustained run-up of similar $ size. These were very large moves in the SP. I assumed the smaller volume run-up was from smaller players following the big guys.
But after these discussions about low volume run-down, I wonder if the low volume run-up was shorts setting things up for their short sales, and this run-down is the same shorts setting things up to get back in / close out. If so, they must smell news coming. They are absolutely screwed if L gets early approval, and they know it.
Or... somebody died in Houston or Miami.
Early Stop Phase 3 Ibrutinib On PFS Data:
January 7, and you guys have probably talked about this already, but thought it might be worth pointing at. This counters Feurstein's recent bad PR. I know Flipper had some other examples.
http://www.investor.jnj.com/releasedetail.cfm?ReleaseID=817572
I don't see any bad news on Ukraine. No insider trading posted for NWBO. World markets are up. US markets are up. I don't see any explanation for the run-down. Only that it started about a minute after I bought another 5K shares. The runup, by the way, started about 1 minute after I sold a bunch of shares. So... that might be the explanation. The machines are hardwired to do the opposite of whatever I do. Well this time the machines are going to lose big!
I like your math etienne555.
You account for the full 100%. Makes me feel good inside.
And the picture you paint of global agencies debating the disposition rings true in-spite of my previous understanding that this would not occur before a PR.
PR "DCVax-L make or break" ignores DCVax-Direct.
I just started following along again, so this may have been said by others, but referring to the PR (which I missed) a few days ago.
Goldman's investing appears to have been a response to the little bit of news that emerged about DCVax-Direct. I guess that was only "we are pleased with what we are seeing"; the suggestion that tumors injected have responded (though other tumors not, at least yet).
If you buy that, it gives a pretty good safety net for the unlikely bad news for DCVax-L. That has kept me from getting too scared. Though I do worry. Not because of the delay, however.
I have wondered too, for some time now, how the DMC would handle subgroups standing out. It did not occur to me, however, that hand-waving a subgroup could create a problem in reaching the next interim milestone for the remaining subgroups. I suppose they should change the milestone... and agree that question could take some time to work out with the FDA. Unfortunately, it seems to me that the same delay could occur if there was a problem with a subgroup. However... my gut is that is unlikely.
I worry about the phase 1 data, since it is famously unreliable in the broader space, but then I look at the positive statements from physicians and compassionate care patients... and I am fine with my position, which is long and substantial.
And they announced the webcast:
I don't remember Flipper or anyone else saying that they can announce material information in the presentation if it is webcast, but I believe that you remember such.
Further, and probably necessary, they advertised the webcast in the PR, provided a link, and do not exclude anyone from watching it.
But I didn't know this, assuming it is true, so thank you for the heads-up.