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The Direct data release and subsequent price increase has made me a lot more patient with issues like HE.
I know what I saw, and people can do all the making up facts, soft bashing and rock hard bashing they want, but I know what I saw.
Sooner or later, if we go through another information desert, I'll naturally need another canteen of water, and a map to the next oasis but for right now, I'm good, and I'm sorry that other people here apparently saw a different presentation than I did.
Inability to produce enough units of vaccine to give timely doses to the patients would be a mandatory reporting issue, wouldn't it?
This might not be true in a blinded trial where the shareholder's interest in having the trial considered valid by the FDA outweighs their interest of being informed of such a development.
But in a non-blinded trial where there is no restriction on releasing material information on a problem that is adversely impacting the company's ability to conduct effective trials so that they would be legally obliged to report it and would have no legitimate reason to withhold it.
For this reason alone, I think you're wrong about this issue.
Amidst an amazing NWBO run up we waste time on Pyrrhonian and his several aliases!
Hopefully, RK can quit having to write novel-length posts about her relationship with Pyrr.
Like I've said before, Mr. Giardino is unwilling to go on the record, in his public capacity as an analyst, with his negative opinions on NWBO.
Until he does, we should quit responding to him with anything other than a challenge to put up or shut up...in public, under his own name.
I think Mr. Giardino values his public reputation as an analyst a lot more than the money he could make or lose with those July puts.
Let him do his worst, or let's just ignore him, and he'll go away.
About the options, I don't know, but that's why I buy straight shares.
As much as I like NWBO I've long since stopped trying to predict exactly when our ship is going to come in.
I just know that it will come in and can afford to wait if it gets delayed.
It's a worse form of abuse to make patients go on placebo when they could be receiving the real deal through HE.
Furthermore, unless NWBO was willing to forgo all US sales, it would need to finish Phase III enrollment so their fear of 'abuse' is unfounded.
Plus, since HE treatment is collectively not blinded, great news for HE patients out of Germany would guarantee full enrollment of patients in the US.
But if you're right then the Germans can't see past trying to get NWBO to pay for as many patients as possible, even if it means giving some of them placebo and gambling with their lives.
Hopefully this will change because,right now HE is to cancer patients what the mirage of an oasis is to people dying of thirst in the desert: a cruel hoax.
The price rise is in spite of, not because of the fact that NWBO had to shut up about Direct for almost a year.
And the price rise only happened now because of the recent Direct release.
Without that release, we'd likely linger in the high $7.00 to high $8.00 range.
Since NWBO has high powered investors like Woodford and given that all of the big milestones are much closer, NWBO knows that releasing information on Direct is no longer necessary to support the share price.
NWBO's position in 2015 is much stronger than it was in 2014 and it will only get better in 2016.
Remember, in a year's time we will almost certainly have the following information:
1. Whether HE in Germany is a feel-good designation with little meaning or a real financial factor for he company.
2. The results for DCVax L Phase 3
3. Whether we've made real progress on EAMS in the UK or not
These three things are individually at least as important as any single intermediate Direct Phase 2 data release and added together, they are much more important.
Absent transformational technological change, biotech is a bubble...but we're not absent such change.
A sea change in biotechnology is imminent and it will play out over the next ten years or more.
Thus, even if the "bubble" bursts in the next year, fear not and just hold onto the shares of biotech companies with great emerging products because all of the quality stocks will be going right back up.
And that's assuming we even have a sharp decline because month that passes gives new advances in regenerative medicine and immunotherapy to come on-line and start turning profits.
Buying NWBO and the other winners in this change is a lot like being able to hop into a time machine and buy any of major technology names of today at the prices they commanded in the early to mid 1990's.
Furthermore, wouldn't an analyst use more conventional and reliable techniques than asking a bunch of people on a message board?
Arguing from silence is always dangerous.
Filling in the blanks with stuff you have flat-out and treating it as facts-in-evidence made up is even worse.
Adam Feuerstein did exactly that by claiming that Ms. Powers' had seen an interim analysis when that was impossible. Flipper recently reminded us of this.
The biggest difference between Mr. Feuerstein's error and Pyrr/Mr. Giardino's is that the former has been foolish enough to stake his reputation on it, in public.
Pyrr has been quite free in expressing his disdain whilst his alter ego Mr. Giardino has so far demurred from publicly flip-flopping in a new article.
Exactly, which is why in a reversal of the usual trend, Phase II should look better than Phase 1 and you know never know, Phase III might even be comparable to or better than Phase II.
Unlike a typical drug, DCVax Direct is a very dynamic product and you can make adjustments during the trials, to the critical factors like the activation method.
This kind of flexibility during the trials is almost unimaginable with conventional drugs, where you are pretty limited to tinkering with the dosage and similar factors of administration.
You're forgetting about the potential for Early Approval.
Plus Direct Phase II will be open label, just like Phase I was.
Until recently, Direct Phase 1 didn't feel like an open trial because of Buzdargate.
Happily Ms. Powers has learned from her mistakes.
Doubtless one of Ms. Powers' key criteria for trial sites will be institutions that willing to give NWBO a free hand to publicize results.
She does not want to deal with people who can be so easily manipulated by the likes of Adam Feuerstein.
Somebody should have told AF that's why they don't play games on paper.
But for Ms. Powers, and NWBO would have gone under.
AF didn't realize until it was too late that her leadership was the X Factor, the one thing that would let NWBO beat the odds.
He just didn't know who he was dealing with.
While I have freely criticized some of Ms. Powers tactics but I always stuck with the company because I knew she had the goods, the savvy, and the willpower to see us through.
I have a 63% + gain in NWBO that tells me I've made the right choice.
Now I can sit back and relax.
Too bad for AF he can't do the same!
Can't Feuerstein just weasel out by saying that NWBO is an exception to the rule?
He could probably say that the $1 billion market cap is fake due to NWBO manipulating the data, etc.
I doubt he's going to be honest enough to say, "Oh gee, I'm sorry but NWBO does have a good chance after all, since it has a market cap of more than 1 billion."
The short squeeze will test the theory that Big Pharma is bankrolling the shorts for reasons of its own and naturally doesn't care if the short positions lose money or not.
I do not subscribe to that theory, most because established players in technology industries tend to be too fat and happy to proactively identify and crush or acquire disruptive technologies.
Thus, I am reasonably sure these shorts are mostly just greedy and hopefully the shorts will be badly burned enough not to stay away once the squeeze is over.
If so, having the shorts and their minions leave for good, will allow NWBO to thrive without the continual toxic cloud of distortions and even lies these folks put out.
Hey, why not, the 5th's in the Constitution!
As for NWBO, I'm really curious to see what's going to happen Monday.
I freely admit I did not believe that we would get a post-ASCO run up or that if we did, that it could last anywhere near this long.
Oh, a Hedge Fund snoop?
And how do you know?
Or is it a guess, (however interesting)?
I'll bite:
The opportunity to commit misconduct (like cherry picking) always exists.
But it is prejudicial to even raise the issue unless there is clear evidence that this type of trial rigging might be happening.
Beyond that, what IMUC did is what IMUC did.
What NWBO is doing, is what NWBO is doing.
Beyond being involved in cancer immunotherapy, they bear little relationship to one another.
Here is an example of why tarring them with the same brush is wrong:
Many child care workers have the opportunity to commit molestation and may or may not be motivated to do so. Daycare facilities have controlled access and are not fully transparent to outsiders.
It would be highly prejudicial to publicly speculate that a specific day care owner, say, Mrs. Joanna Q. Citizen might have committed molestation simply because the opportunity may exist and because someone in another daycare in another state did it at some point in time.
Just the public speculation could hurt or even destroy Mrs. Joanna Q. Citizen's business by causing people to withdraw their children or not enroll them there in the first place.
Similarly, speculating, without evidence, that NWBO might have cherry picked patients to inflate Direct Phase 1 results could hurt NWBO and more importantly cause both patients and investors to miss out on an opportunity.
Happily, the time when message board posts about NWBO, either good or bad, can influence this stock is quickly drawing to a close.
The burden of proof is on someone raising an issue.
That would be you.
But as a courtesy, I'll take a stab at proving it as much as someone without direct knowledge of the trial can:
DCVax L and DCVax Direct target all tumor antigens.
IMUC had a product that targeted a short list of specific tumor antigens.
With IMUC, cherry picking patients was both possible and quite useful (provided honest results weren't important, for whatever reason).
With DCVax cherry picking patients will yield you little if it is even possible.
The only cherry picking NWBO should do and explicitly so, is that DCVax patients should have a functioning immune system.
You cannot fairly be expected to activate something that isn't there.
Remember that many products are not meant for patients with compromised immune systems.
These products they still get approved without having to prove they work on patients they aren't meant to be used on.
That's why you get all the disclaimers on certain drugs saying you can't use them if you have a bad immune system. Usually this is a safety issue, but sometimes it may an efficacy issue as well.
I also caught it at the end, but I don't think it has to do with NWBO. From what I can tell it was about interfering with certain kinds of stem cells in GBM tumors which is quite different than DCVax.
I think they were talking about preliminary studies and not a treatment that is trials, let alone Phase 3.
Unlike a typical drug, I think DCVax could actually get better results in Phase 2 and Phase 3 than Phase 1 because they're able to take what they learned about dosing and multiple injections and really put it to work.
That would be a dramatic reversal of the usual pattern with new drugs and treatments where Phase 1 looks great but then Phase 2 and 3 do not produce results that are as good as Phase 1 or the preclinical studies.
Thanks! Happily, we can be certain that NWBO will inform DCVax Direct patients that their tumor may temporarily enlarge as part of the tumor cell die-off process.
I'd call it false progression to avoid confusion with Phase III brain tumor patient's psuedo-progression since I don't believe that psuedo-progression was caused by DCVax L but was already present.
Now that we know about the false progression issue, that information can be included in the informed consent for patients enrolling in the Phase 2 trial.
That way the patients will know about false progression is and what it may mean and will not almost get scared out of staying in the trial by a radiologist unfamiliar with cancer immunotherapy (as in the case Dr. Bosch related at ASCO).
I wonder why he waited almost 2 1/2 years to get the vaccine.
I would say he's a psuedo-progressor because I cannot see a patient on Standard of Care surviving without something better between progression started in April 2013 to getting the first vaccine just 10 days ago on June 2, 2015.
Still, like you said, it's interesting.
Good point, either way, we win.
Sorry, I'm not that selfless, and if I hold we'll still make money, just rather more slowly.
They do not even get all of the NWBO shares they shake loose.
Some will end up in the hands of longs and every time the shorts manipulate this stock and fail, it costs them money to pull and reduces the number of shares held by weak hands.
Ms. Powers is unlikely to lower the boom for its own sake but yes, another piece of news,would do the trick.
$10.00 is an important psychological barrier and if we can consistently stay above it, that might be enough to start things rolling, even without news.
All we need is to get one short to fall and he or she will knock over the rest like a bunch of dominoes.
This is probably Feuerstein's favorite quote:
True and if you know the pattern you can make money:
Big rise on news
Smaller drop on manipulation by shorts
Drift downward for a long time
Big rise on more news and so on
Eventually, NWBO will either have really awesome or really catastrophic news, and then this pattern will be broken.
At that point NWBO will establish a new pattern.
But until then as a long, you can feel like a big shot while the stock goes up for a few days and your net worth spikes but just know its coming back (at least a little).
Instead of being depressed by the pull back, just buy more cheap shares near the low point.
Why buy shares near $10.00 when the shorts are willing to knock NWBO's price down a lot lower for you?
That is why we're down today and why the shorts can so easily walk or even cram down the share price.
We'll find support when NWBO longs think this stock can't go any lower and start buying cheap shares.
This creates a deceptive appearance:
In the short run, longs look like they're losing to the shorts.
In the long run, the shorts are actually subsidizing long-term profits for the longs.
If I sell it'll skyrocket, if I hold it'll drift downward.
So, I am doing what I have always done, buy on big dips and hold.
Overall I'm up 55% in NWBO so far and others are doubtless doing a lot better than I am.
That means my strategy is working just fine.
I won't take a chance of being out of this stock when the big move happens.
If you think last week was scary for the shorts, you've seen nothing yet.
Thanks Afford, but I had it right, NWBO, not Cognate owns the facility because that will lead to self-sufficiency.
Cognate has other concerns and cannot put this disproportionate share of resources into NWBO forever.
Both sides will benefit in the same way that conjoined twins profit by being physically separated even though they remain close as siblings.
Eventually, NWBO will have to stand on its own.
When that happens, Cognate shareholders, including Ms. Powers, will make a lot of money from having stuck by NWBO during the hard times when it would otherwise have gone under.
Insanity is a strong word, and shorts fill in at least as many blanks as longs.
First, NWBO is able to patent large parts of their process but I am not sure everything is fully covered yet. This is why Dr. Bosch did not characterize the difference between Method A and Method B for the DCVax Direct trial. Ms. Powers used the infamous "secret sauce" language for the same reason, because NWBO wanted to make sure its intellectual property is covered before it gets too specific with what it is doing.
So yes, NWBO has a growing patent portfolio. Indeed, the company has alluded to the idea that their intellectual property with respect to manufacturing methods could generate licensing revenues from other firms. Others would be better at finding the exact quote but I certainly picked up on that point and I doubt I'm the only one who heard it.
Second, the UK facility is obviously a very bullish bet by NWBO executives.
If as Ms. Powers, has indicated, NWBO is to become a strong biotechnology company that will go the distance to commercialization on its own, this manufacturing capacity will be critical.
Having Cognate own the facility does not advance the goal of making NWBO self-sufficient let alone a big player in this market.
HE would be the icing on the cake, and after the virtuoso Direct data release, I no longer harbor the same level of doubt that Germany will get move on.
He also conjures debt out of thin air. When one tries to argue that NWBO hasn't been effectively addressing the problem of cost effective manufacturing, well, that shows how little one knows about this company.
Most small companies at this stage in the game focus only on approval of the technology.
That's playing checkers.
NWBO is planning two or three moves ahead and cost-effectiveness is at the forefront of their thinking.
Now that's playing chess.
Sam Spade's rebuttal using the Direct Data:
Exactly, radiation and chemo are the tornadoes not DCVax.
If there were any evidence, any evidence at all, that DCVax causes "collateral damage" they might have a point.
But we have seen no such evidence from the DCVax-L trials, the DC Vax Prostate trials, or the present DCVax Direct Phase 1.
This does not even account for the fact that when you cherry pick antigens, tumors tend to adapt and stop expressing them.
I hope you're right but you could use this to argue the opposite.
Such a dramatic rise (assuming there's no more news tomorrow) would normally be followed by a cooling off period, not a rise even more dramatic than we have already seen.