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How About Dogs the Need it?
I wish they had tested / perfected Direct on Dogs. But only dogs with naturally occurring tumors. And no sacrifice of the dog afterwards. They just go home to their thankful owners. Plenty of dogs out there that need it. I lost a dog to cancer about a year ago. It was a great dog. And it had the cancer for years before it really took off. Plenty of time to try different variations on L.
Mice are too far from Humans... but monkeys are a little too human, and they are caged for life.
Your Right. Amgen's Melanoma-Killer Virus Showed 30% Complete Response.
It was a subset of the un-injected tumors that only had a 7% complete response. The rest of the un-injected tumors had no response.
30% is pretty good given the simplicity of the procedure. And even 7% complete response in a subset of un-injected tumors is pretty good.
So, this is exciting! Sorry Amgen! I stand corrected.
30% X 67% = Only 20% of GBM Patients respond to CLDX's Drug.
"EGFRvIII is expressed in tumors in about 30% of glioblastoma patients."
"The majority (67%) of these patients developed titers above 1:12,800. Such immune responses may contribute to the direct destruction of tumor cells expressing EGFRvIII."
They would have only tested on patients with tumors that expressed EGFRvIII.
And CLDX only has only 2 drugs at Phase III in their pipleline. This one is much inferior to DCVax-L. Is their other drug more valuable than Northwest's DCVax for Prostate? Hard to imagine that would be the case. Then why is their nominal market cap 7X Northwest's nominal market cap?
Maybe that is because they have the AF's on their side. The professional ArshFarks. The winners of the coveted Golden Knee Pads award for crooked journalism targeted at biotech companies with potentially successful therapies to cure diseases that have been shorted by the AF army's leaders.
Celdex for GBM is only for 20% of Patients,
and it doesn't do that much for those 20%.
I recently criticized AF for throwing into his mud flinging that Celdex has a GBM product in phase 3 in Europe. I was wrong saying that the product is similar to DCVax-L yet he promotes it while saying DCVax-L could not possibly work.
Celdex's product is very different from DCVax-L. What I should have said is that their product, on paper, is crap compared to DCVax-L, so why does AF even mention it when talking about DCVax-L.
The Celdex website says that this product is only worth testing on 20% of the GBM population. When tested on that population they are claiming a 6 month extension of OS over standard of care. Compare that to DCVax-L which has shown much better results on the entire GBM population. AF is consistently full of crap. I am only full of crap once in a while.
http://www.celldex.com/pipeline/rindopepimut.php
"Rindopepimut is an investigational immunotherapy that targets the tumor specific oncogene EGFRvIII (also known as EGFRv3), a functional and permanently activated mutation of the epidermal growth factor receptor (EGFR), a protein that has been well validated as a target for cancer therapy. Expression of EGFRvIII correlates with increased tumorigenicity in mouse models and poor long term survival in clinical studies of glioblastoma patients. In addition, EGFRvIII positive cells are believed to stimulate proliferation of non-EGFRvIII cells through IL-6 cell-to-cell signaling and to release microvesicles containing EGFRvIII , which can merge with neighboring cells, transferring tumor-promoting activity. EGFRvIII expression may also be associated with tumor stem cells that have been identified in GBM. These stem cells contribute to resistance to cytotoxic therapy and tumor recurrence. EGFRvIII is expressed in tumors in about 30% of glioblastoma patients. It has not been detected at a significant level in normal tissues; therefore, targeting of this tumor-specific molecule is not likely to impact healthy tissues.
Rindopepimut is administered via intradermal injection and consists of the EGFRvIII-specific peptide sequence conjugated to the carrier protein Keyhole Limpet Hemocyanin (KLH). Rindopepimut stimulates the patient’s immune system, inducing pronounced EGFRvIII-specific humoral and cellular responses. 85% of patients in clinical trials evaluating rindopepimut developed significant anti-EGFRvIII antibody titers, which increased with time on study. The majority (67%) of these patients developed titers above 1:12,800. Such immune responses may contribute to the direct destruction of tumor cells expressing EGFRvIII.
Three Phase 2 trials of rindopepimut have been completed in newly diagnosed EGFRvIII-positive glioblastoma patients with consistent results—ACTIVATE, ACT II, ACT III —and multiple patients continue to be followed for survival. Across all three studies, rindopepimut has been generally well tolerated with generation of robust, specific and durable immune responses. The most common adverse events for rindopepimut include injection site reactions, fatigue, rash, nausea and pruritus.
Pipeline - Rindopepimut
"
Only 7% Complete Response; Amgen Virus for Melanoma
I read that to say that there was complete response in only 7% of the tumors directly injected, and they have not seen anything yet in tumors not injected. Later they make it sound like they saw response in tumors not injected... but it is ambiguous as I read it.
Hopefully DCVax-Direct will do much better than that on the wide range of solid tumors it is to be tested on.
Maybe there is more than one Alexander out there... I guess there are 77. Not sure which one I am talking to.
Efficacy is still pending/outstanding. That is pretty much agreed. Very few here think there is any chance that it could be a halt for futility. Many think that possibility was literally ruled out by the NW statement that the safety portion ended in continue.
Personally, I do not think the Co PR was intended to say that a stop for futility was ruled out, but I don't think there is much chance of that for a number of reasons. One argument is that they just wouldn't do that being so close to the next interim review at this point. Other arguments rely on projections from phase 1 statistics, which is a little scary. Other arguments point at the numbers collected from compassionate care. I think those are convincing arguments. Those numbers make a stop for futility essentially impossible unless samples were somehow manipulated. Others may know how they prevent that. Myself, I don't know how that works. I understand what double-blind is, but I don't understand the mechanics of how they deliver control or experimental treatments to patients. But if you believe that system works, then I don't see how you could worry too much about a stop for futility with an 80% response rate in public compassionate care use.
I think I have heard that there are 200+ compassionate care histories. You would think that the Germans examined all the compassionate care case histories as well as the Phase 1 data, whether or not they gained access to the Phase2/3 data.
vmlg
Regarding sending you my SEC filing. (I said I would join ihub so that I could message you directly).
The main reason I would join ihub is so that I can individually message people. But I won't do automatic renewal on a credit card. So my option is buying 3 years worth or paying $20/mo. The $20/mo would be marginally acceptable, but they have another $10 fee if you want to be able to read your messages for free... with no further explanation. WWTTFF?
Love the site, don't like that business model.
So, if you want to give me an email address, I would contact you that way.
I agree about the SEC.
As I did just a little bit of research and thinking, while preparing my complaint to the SEC, I quickly lost steam, realizing that they can't possibly be a real functioning organization. And if they are more corrupt than incompetent, I'm not sure that handing them your strategy makes sense.
Still, I think you have to go through the motions. Maybe just hold back your ace or a few of your aces.
Ok I believe you are legit vmlg17.
I got started late this morning, and as often happens, I was writing my reply to your first post while you were typing your next post.
The eyeball thing allows you to bypass the secret handshake, but I don't want to post in public on the matter. I will have to join ihub so I can post to you directly.
AF: I decided you are a great guy who is just misunderstood. You have nothing to worry about. I'm nobody anyway...
No... but I don't recognize you vmlg17, so I am hesitant to copy you my SEC filing. I know you are probably a legitimate long that just doesn't post very often, but you could be AF himself, or a minion to the minion.
And if you are.. then again; no worries. As you were. Pyrrho was right. Nothing really matters. Certainly not cures for brain cancer.
And Only 2 Founders: Thank you Long.
I just knew they both worked for The Street. That was not enough of a connection.
Yeah Pyrrho.
Why don't you join us all back here on middle earth. No shame in being a civilian. Hell, even Flipper is happy being a civilian. Ou likes it. Etienne likes it. Foxhound likes it. BBKing likes it. JackLondon likes it. Afford likes it. Austin Likes it. TheRedBaron Likes it. Hodge, Long, NS, Lunatic, The Follower, Staccani, DrChuck, Alexius, TZOR, MolBio, Moosebite, ExCeo, BigFatBanker, Anderson, GPB, Sitiain, RRRichmond, Afford, SwampRabbit, f3ttef, Rene, Olive, Diamondjim, buzzcock, iclight, BigTony and me; we all like the lack of responsibility.
Think of all the extra time you would have to make money to buy Northwest Stock. It takes a lot of time to be a moderator. A lot of energy. At what gain?
At what gain?
Food Court!
That's even better than the toilets! Much better!
http://www.exposeadam.com/
Adam Feuerstein gets around, as some of you probably know.
Does anybody have solid evidence that Feuerstein works for Cramer? I have heard it again and again, but I don't know of any solid evidence that is the case. I need that evidence.
I think your wrong Dok about insurance beni not having been previously mentioned.
They may not have previously used the word insurance, but I think they said that the German hospitals had applied for full reimbursement, rather than just the 50% reimbursement already setup. I think I assumed it was going to come from their Fed, but it turns out is coming from insurance if things proceed as described.
So... not clear to me if this is something out of the blue, but it sure is good news.
I agree Dok.
5 ASCO Booths! Good stuff BB
Looks like they are planning on kicking some major ASCO!
Who is Joseph Hill? And why would he/they publish a write-up on DCVax-L today and not mention the German decisions or the fact that the efficacy part of the first interim on Phase 3 is pending? Very odd.
They did however state that the results of phase 3 should be out by the end of 2015.
Lot's of odd things lately. I was joking about the red mushrooms with white dots... but it looks like I had better at least eat my spinach and get my regular naps in preparation for the unknown.
Funding May Not Be Needed and Is Not Imminent:
The NW CEO said recently that they were going to be looking for non-dilutive funding in the future. Doesn't mean that is going to happen, but it means it is probably a real possibility. This news from Germany was bigger than I expected because of the insurance approval. I don't think that was talked about before the announcement. If there was a shot at non-dilutive funding before this news, and if the news is as important as I want to believe it is, then they should be in a very good position to find non-dilutive funding.
If not. The last estimate that I heard for when they would need money was May. That was John's estimate as I recall.
ASCO is late May/ Early June. It ends June 3. That is the most logical time for them to do funding. How could they stretch from May (if that was a good estimate) to June? Maybe this recent PR and subsequent activity generated cash through warrant's being exercised. Given the enormous share volume, it would seem to me to be a reasonable assumption. That would probably carry them out to June or further. So... it is probably June. And the PR's will probably be honest and the resulting increases in share price deserved. So I have no plans on trying to play it as an anticipated pump and dump. I did not gain shares last time I tried it, and it cost me a lot of stomach lining.
That's if they need funding at all.
I think we have gone in a circle on this.
I started to say this earlier.. but couldn't remember when or how we got clarification.
The initial perception of the German PR was that it meant the German's had some knowledge of the Phase 3 data. But later that perception was altered to the belief that they could not have had any official communication. I think it was Larry Smith's article on the topic. Yes, it was Smith's article.
I guess Larry could be wrong, but most of us here consider him to be the most reliable opinion available.
Feuerstein off the Street!
Feuerstein off the Street!
Feuerstein off the Street!
Feuerstein off the Street!
Feuerstein off the Street!
Get it.
After the SEC does nothing in response to our complaints we picket the main office for "The Street" and tell our story to newspapers, etc, until Feuerstein gets fired.
In the mean time, sign up for Smithonstocks. Maybe if enough people sign up he can afford postings on the newswires.
Again, you can use Paypal to sign up, and you can easily cancel the automatic renewal on Paypal afterwards. You don't even have to talk to anyone to cancel it. It is there as an option on the Paypal website. And Larry Smith doesn't mind. In fact, he suggested it to me when I inquired.
Feuerstein doesn't have to trip the SP for a long period of time. He only has to effect it briefly at the right time during a PR campaign prior to a stock offering. And to my recollection, he has done just that in the past.
He's getting bolder and more dishonest as whoever is behind him is getting more desperate. Or so it seems.
I am not complaining about Feuerstein saying critical things at critical moments, I am complaining about him lying through his teeth, deliberately damaging the perception of Northwest at critical moments.
I wish you luck in getting more shares, but I don't care about your dips if they come from the libelous venom of a divisive minion intent on preventing this company from succeeding.
We need to take the microphone out of this SOB's hands.
Not so Pyrrho.
How long have you been watching this stock?
SEC Complaint. Something Important for NWBO
This blog typically focuses first on the technical aspects of Northwest's therapies, second on the financial prospects and day to day events effecting share price, but a strong third on the reality of how incredible these products might be for the people that need them.
Those that believe these products and the company could bring about major progress in treating and even curing cancer will hopefully realize that complaining to the SEC about Feuerstein is something very real that they can do to help this effort.
The fact is, this company will probably need more funding. Maybe not, if things go right here, but probably. The amount of funding they will be able to obtain will be dependent on the public and institutional perception of the value of the company. There will be PR's presenting real progress by the company in these efforts, timed to gather attention, and new investors. Those new investors will fund these final stages of development as the company approaches being able to run off of revenue.
Things could go wrong. There could be a market crash 3 months from now due to a world event. If so, funding will be hard to find until the markets recover. That could be weeks, or years. The company has to be able to market itself to investors by presenting real progress, and obtain enough funding to get them over this hump. If Feuerstein is allowed to continue to flat out lie about relevant facts, effectively negating truly deserved increases in company valuation, then he will effect the ability of this company to ensure funding. That's a big deal if you believe that this company is in the process of effectively curing cancer. So, if you believe that, you should take the time to write your complaint to the SEC.
To me, just the fact that there is nothing done about illegal maneuvers like this is very disturbing. I see things like this throughout our system here in the US. I don't understand. But I think the system does work if you push very hard.
Strange Posting Under Press Releases:
Nasdaq section on Press Releases has been unstable like Yahoo Finance Graph for NWBO. Sometimes listing news articles that are not press releases. Then it reverts back. Has been this way for a couple of weeks at least.
A few minutes ago it added a news article that sounds like the results of the DMC review, but is not. Seems to be a component of one of those moves that Cramer talked about in his video.
In the end there are two links. One goes to a Schwab advertisement, the other goes to an add for a service that has done a write-up on Northwest. It says the write-up is free, but when you go to the link it is a sign-up page.
I verified that there is nothing new in press releases at the Northwest website.
Why would the NASDAQ allow itself to be involved in such crap?
http://www.nasdaq.com/symbol/nwbo/press-releases
http://www.nasdaq.com/press-release/approvals-clinical-trial-results-stock-summaries-data-publication-and-conference-participation--20140313-00377
Fox: The delay appeared illegal. That begged an explanation. Having failed to give it immediately, they were subject to AF before giving it. At that point they could have published the explanation for the delay without mentioning AF. I would agree with that criticism.
But it's all non-central stuff. So they are not experts at dealing with attacks in real time... so what? I don't want them to be experts at dealing with attacks. I want them to be experts at exactly what they appear to be experts at...
Ate My...
"Eine Deutsche Ubersetzung Ate My DCVax Pressemitteilung"
That was funny. I will give AF that credit. But these matters are too serious, and involving too much money for that to help him. Good to hear that the Street has his back because AF's pockets are not going to be deep enough, and making license plates or filleting Tilapia doesn't pay enough.
Short: NW should have posted the explanation of the delay soon after the PR on Germany. That would have prevented the legitimate part of AF's rant.
That said, it is not halo-ing to say that Linda Powers is wearing so many hats that these kinds of matters are going to have to slip once in a while.
Can you imagine all the different things going on at the same time in response to those decisions by Germany? And all the other things going on for the company right now.
This just isn't the meat of what this company is about. It is absolutely unbelievable what this company is accomplishing with such a small staff. Unbelievable!
I don't have to hold anyone responsible for not having the perfect response to this criminal every time. Why would you criticize that instead of criticizing the criminal. Ridiculous.
So "The Street" is liable.
Negative posts are legal... and there aren't enough of them, sometimes on this blog.
But flatly false negative information on a widely read website, on a regular basis has some threshold of a need for a legal response. I think AF is clearly far enough over that line that concerned people should take action at this point.
AF knows that Northwest has no control over when the DMC makes their decision, yet he has said multiple times now that Northwest has lied about when that recommendation is coming. This is the most published advisor in the biotech realm pretending to not know that the DMC makes the decision as to when they are done.
This guy is a crook. Period. And he does real damage. Even if the net effect, by chance, did not end up harming Northwest, there are certainly hundreds individual investors that have been forced to sell due to leveraging, and or frightened into selling due to misinformation, only to see the stock pop out of their range later on. These people have reason to believe that if it gets broadcast on a well known website that there is some assurance that the information is accurate. I'm not saying that it is smart to leverage in biotech or that it is smart to believe everything you read... but I am saying that it's illegal for AF to do this and it does damage people. This is real. And he really is going to get sued. You want to stand by him, I think you are making a big mistake.
Oh. I see Flipper.
But Pyrrho is joking when he says he likes AF. He likes the dips because he is desperate to buy more shares. It just makes it funny to say that he likes AF instead.
But I see why you replied the way you did. I actually forgot that he had made that comment.
NWBO stock went up 50% in 2 days.
In doing so it met Oppenheimer's share price projection. Thus a hold recommendation, down from buy. That simple.
Aside: I do think people have gone overboard hammering you for your posts today. They should be hammering your posts, not you. I didn't agree with some of what you said, but you post both positive and negative, from my recollection.
(In answer to your posted question of why the Oppenheimer downgrade).
I don't follow you Flipper.
You always make sense... I think something is lost in translation here. I didn't think Pyrrho had said anything about F-Stein. He was defending trading as opposed to long hold investing. Mostly trading to try to get more shares.
I have mentioned my trading in the past. I should add that I have mostly lost my ass trading. I had more shares when I started 4 or 5 months ago than I have now. Some of my trading was done because I needed a crown, or a head gasket... but most was done to try to get more shares. Such as during the PR series before the last finance round. That was predictable. But even in that huge up and down swing I lost shares! I made money, so that forced taxes... and of course still ahead $ wise, but when all the smoke cleared, I had less shares!!!!
So I try to just hang on to shares now through the volatility. As you do. But that is a practical decision, not a moral one.
Bad wording Pyrrho "You Don't Have a Year".
Bad choice of words on my part. But this might be your last day. (Correction from 2 days min).
But who knows.
I am kind of hoping for a dip so I can get a full 1Kx2 shares into a Roth IRA for last year and next year. Though I don't think I will qualify next year due to NW windfall. But maybe I will hang on to my stock long enough to stay under max income level.
4 Days max allowed to hold news would be Thur or Fri morning if they had the DMC recommendation before announcing Germany. I have thought the same at times, but it doesn't look like they had much leeway on when to announce Germany.
But if that is the case, this could be the last day to invest on the cheap.
Not sure what a recommendation of continue would do though. That is the big question nobody is talking about. I am sure some think it would cause a drop, but after the German news, I don't know. I think any such drop could be more than built in now. But... who knows.
In fact, F-Stein may have enough people afraid of SP Armageddon that a continue would cause a rise in SP.
You don't have a year.
You've got 2 days, 8 days, 2 1/2 months, or 4 1/2 months, but you don't have to the end of the year to accumulate stock. Sorry man.
Exactly the PR I hoped for.
The accusation of a delay by Feuerstein was an accusation of Northwest doing something illegal. I think that in general, Northwest has to focus on their jobs, and not waste time with someone like Feuerstein, but not when accused of doing something illegal. That they needed to respond to.
Your rant here made no sense. On the one hand you say they should not respond to this idiot; then on the other hand you say they should have responded to every detail. I think they responded to just the right amount. The accusation of doing something illegal.
Thank you Austin.
I think we really should do this (file complaints about Feuerstein with the SEC). Lots of talent on this blog. Who knows how much on the sidelines. Many of his rants are so straightforwardly illegal. Just doesn't make sense for us to tolerate it, while it does make sense for Northwest to stay focused on their jobs.
I think all his posts are pretty easy to find at the street.com.
Cologne was a mixed bag for me anyway.
The numbers circulated about the work in Cologne were exciting, but it never made total sense that Northwest was something new if such a large volume of success had been ongoing for years in Germany. And their treatment regimen was a little different from DCVax-L. So if they had the stats bragged about, you had to wonder if NW should be doing things a little differently. Due to these concerns on my part, I am kind of happy to hear a critique of the work in Cologne.
So, maybe Temador is needed. I have heard over and over again that it is definitely synergistic with DCVax-L when used during the initial stages of treatment. I just think it is transparent that the optimum number of cycles of Temador when DCVax-L is being used will prove to be less than the current SOC. That reduction might be less than one cycle... meaning that there is no need to reduce cycles, but I think that is unlikely. I would guess that there is at least a 33% reduction in the optimum number of Temador cycles in the secondary period. I think that reduction will improve OS while helping offset the cost of DCVax-L. And I'm not a quack... I think you have to be a Doctor to be a quack. I'm a doktor.
Maybe Oppenheimer wants more shares.
Or maybe they are saying perform based on an expectation of a continue. That is generally considered the most likely outcome in general with all biotech in this situation... so it is the conservative prediction. They are just saying that $10 is about right with a continue from the DMC. They are not saying that is right if they recommend a halt for efficacy for all or any subgroups. But they don't have inside knowledge on that outcome, so they have to go with the historical stats.
If so, I hope it's not Temador behind F-Stein. Temador may or may not be in jeopardy if DCVax-L works well. I don't think that group in Cologne uses anything like it. I suspect that the Temador regimen will be reduced eventually.
There is a lot of money in Temador. I read an older article that listed it as 2/3 the cost of GMB treatment with all costs considered. I'm not sure what the cost breakdown would be these days.
That's Merck. I associate Merck with the Merck manual, which is a tremendously useful medical publication. Maybe it's not the same people. I want to like Merck. Nobody will like them any more iff they find they are interfering with a better treatment. It would make J&J's problems look like an incident with the Maid, and Merck would not be invited to any superbowls for a long long time.
S.E.C. complaints first.
Looks like I will have to make these decisions. I think that many individual complaints to the SEC about Adam Feuerstein would be the best starting point.
There are almost certainly big $ behind him that know in advance when he is going to post his lies. The advance notice allows them to play the dips, among other things. That is absolutely the type of thing that the SEC is supposed to be preventing. But my understanding is they have to start with complaints. They don't just initiate action on their own.
The slander dimension would also be important combined with advance notice.
I need a minion. I have never had a minion. Any volunteers?
The first thing I need you to do is to read the Dodd-Frank Wall Street Reform and Consumer Protection Act and report to me the relevant sections. In 400 words or less.