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Yes this old chart, thanks flip.
marzan, according to flip's chart the treatment arm will most likely see over 40% PFS at 30 months, the blended data being 25% at 30 months when most all control arm patients 95% would have progressed by then. imho amazing stuff.. and since they excluded most psPD the data will look even more amazing for PFS, with OS being more confounded due to crossovers.
good one senti, at least we can count on him for something useful... and it's not journalism.
nice senti, you should be nicknamed Nancy Drew... They would do better to hire you than that awful law firm they hired.
Flip so you expect to see more dramatic curves due to the exclusion of most long lived psPD patients? Could you draw a chart of what you think the curves would look like for our Phase III trial? Thanks.
In a way is it best we excluded most psPD patients because they would of further confoundment of OS due to the crossover option. This way we can see how DC-Vax L really works for the majority of Ngbm patients. I think our OS data is going to look pretty good due to the fact the trial has lasted so long as to truly see how long the PFS treatment patients survive.
thanks flip, PFS will be crystal clear between treatment and placebo arms. OS for crossovers to DC-Vax L will help it get approval for Rgbm as well, imho.
Looks Statistically Significant to me. Safe to say that Most All Placebo patients have progressed by now since we are 29 months past last patient enrolled. PFS and OS eventing? What is the rate now? Thanks flip awesome chart.
flip, next month we will be 48 Months median enrollment from May/2014. How many PFS survivors do we have? still we are not impressed? Say what? just to be clear. We are talking Ngbm. I personally am way beyond impressed. LP is making sure there is no room for any doubt. It will be crystal CLEAR.
any reasonable person would conclude you be right! Except Mr.AF he has bowel movement issues imho. He is obviously not scared of Mr.Black btw.. LOL
the kicker is they said over 90% are on DC-Vax L. Most all placebo control have progressed. The ones still PFS are most likely in treatment group. Can they make it any clearer? Thank you.
Precisely, checkmate.
I wouldn't be surprised if he made that up btw. Just heads up that they make up things all the time. imho He use to drive RK insane with endless infinite loop made up arguments...
be nice if they gave it rest.
ATL excellent video, thank you! Dr. Cobbs is building on DC-Vax trial experience to target mRNA cancer stem sells with dendritic cell vaccine and CI. Sounds familiar he must know DC-Vax vaccine throwing the kitchen sink of all cancer proteins of patient's own tumor works for 20% or so long tail of patients, just as Dr. Liau has said for years now. We have a new SOC folks, thanks! At least for those 20% of patients that will be based on their biomarkers but I think it may prolong life for other patients as well just not as long as the 20% DC-Vax may provide a possible cure for. DC-Vax Direct will be amazing with CI, possibly eliminate additional surgeries.
Hysterical, funny, ROFLMAO
Like, IkeEsq nice response
Beauty, it appears, can be a Beast...
makes sense don't expect purr to have any, it's complicated...
It's hard to spin 80 plus survivors of Ngbm as anything but positive for a trial that has lasted over a decade and midpoint gonna be 48 months in April? I don't know how they will spin that one? They are way too many survivors in this trial for brain cancer, the vaccine looks like it cures 25% of Ngbm patients for 5 years or longer PFS... LOL btw it has side effects of mild fever, aches... oh and you can go back to living your normal daily life with no chemo or radiation treatments... Looks like you are pretty good at counting cards evanstony. Congrats on doubling down looks like we got a winner for the next coming decade or more...imho
yup it's pretty profound they are publishing a paper on blinded blended results that blow away SOC. Imho Dr.Liau will have validation no matter what the spin, reality is 25% of DC-Vax patients are alive well past three years or more.
senti, they don't need to spend money on lawyers telling them what they already know. They could just spend the money on AF to get off their backs. He would gladly write a good piece on them if they would just grease him. imho they are fighting the wrong battles. They should hire a good project manager to keep them on track instead of incompetent law firms that over bill them cause they don;t even bother to read or respond to emails or bills. Chardan is another example of dropping the ball. They need to hire some competent staff instead of putting out fires.
nice post etienne.
Imho I believe Dr.Bosch, & Dr.Liau, paper is done, submitted and waiting to be published. I believe them. Thanks for your updates.
Amen, exactly LP deserves all the credit for having the Vision to support LL in her brilliance of DC-Vax, that we have made it thus far is all due to their perseverance. She deserves to profit more than anyone else other than LL. We are all along for the ride, imho though a very bumpy one.
good attitude TC, they be lucky to have you working for them. imho
Sojourner, how can they cover if nobody sells to them except themselves? They do have the shares Chardan, cantor fitzgerald, placed for them last year. Seems like they are just churning their shares. No longs have sold but most have averaged down. imho, Woodford still has his shares.
nobody cares what he thinks, a dweeb, a tool plus he is ugly inside and out, nothing redeeming about him except he may have a good dog...
Thanks sojourner, I enjoy your posts as well. I guess they are unhappy cause we longs just keep buying cause we see the unlimited upside with time.
the point is AF is a HYPOCRITE, support cancer research??? looks like a front to me, he does not give a hoot about anybody but himself. Imho otherwise he would not bash without any thought as to the consequences of his actions in delaying life saving therapies like DC-Vax. He has made up a bunch of lies to suit his agenda. That's the truth of it, the courts dismissal of all his false accusations and lies. He is the biggest piece of White Trash I have ever had the misfortune to know in the biotech space. LP has been gracious to her credit.
Thanks cherrytree, nice analysis.
Relentless Adam Feuerstein, a biotech reporter whose relentlessly negative blog posts for thestreet.com this year have not only been filled with exaggeration, mischaracterization and half-truths, but curiously have also coincided with the spikes in short trading.
Here we sit still at 30 cents and the shorts are still not happy! Go figure, they are always unhappy... LOL
AF should retweet Jimmy ringing the bell after his Chemo treatments, maybe that will make him HAPPY!
The guy is one sick Dude, so we have to forgive him for he is really sick, it is not his fault he is ill with narcissistic personality disorder.
Thank you beartrap, great info.
Northwest Biotherapeutics stock woes highlight the harm of short sales
By Steven Pearlstein Columnist September 27, 2014 Email the author
The past couple of weeks should have been heady ones for Bethesda-based Northwest Biotherapeutics.
The small biotech firm, with an innovative new vaccine treatment for brain, prostate and other cancers, had just received an initial green light from British regulators to offer its drug to doctors and patients even before its definitive Phase III trial is completed in the United States. The approval was the first under a new program designed to speed the process of getting promising treatments to market, and it follows a similar decision by Germany in March. Both European regulators cited independent analyses of results from earlier brain cancer trials showing that Northwest Bio’s immune therapy doubled the average of 17 months of extra life now provided by the standard treatment of chemotherapy and radiation.
But as it happens, Northwest Bio’s stock, after a brief upward spike, ended the week down 11 percent below where it was the day before the news from Britain crossed the ticker. And therein lies an eye-opening tale of how hedge funds and their Wall Street allies stifle innovation and damage the economy in their relentless pursuit of short-term trading profits.
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I’m talking, of course, about the “shorts” — investors who actively bet against companies by borrowing shares of their stock and selling them in the hope that the price will go down and they can buy them back at a lower price before returning the shares to their rightful owner. In theory, short-selling enhances the efficiency of markets by bringing in fresh information and capital. In reality, it has contributed to turning financial markets into a giant casino which is easily rigged for the benefit of insiders.
Biotech stocks are particularly vulnerable to manipulation by the shorts. They tend to be small, with low share prices and relatively few shares actively traded. And because of the high risk involved — relatively few biotech companies ever succeed — share prices tend to be volatile, easily moved by rumors and news of regulatory action.
These characteristics make it easy for a handful of hedge funds to anonymously drive down the price by selling borrowed shares into the market at the same time, creating a self-fulfilling momentum that scares off other investors. Even when they can’t get ahold of enough borrowed shares, they might sell the shares anyway and simply fail to deliver them three days later when they are due. That’s known as a “naked” short, and it’s illegal.
The shorts’ tactics, however, extend well beyond the trading room. As the nonprofit advocacy group Citizens for Responsibility and Ethics in Washington (CREW) lays out in a recent white paper, shorts are active in anonymously feeding false and misleading information about their target companies to friendly analysts and bloggers while using social media to attack the intelligence and motives of those who view the company favorably. They enlist plaintiffs law firms to issue press releases soliciting shareholders to sue the target companies for securities fraud. And they pepper regulators with threatening letters and fillings demanding that they investigate their targets or deny them product approvals.
Such tactics make it difficult and expensive for biotech firms to raise the large amounts of capital they need to conduct drug trials and build production facilities. They were all used in recent years to cripple Dendreon, another company that is a pioneer in the use of immune therapy for cancer treatment, which was so weakened by the shorts that it has failed to recover even after receiving its much-delayed FDA approval. And now they are after Northwest Bio.
As you can see from the accompanying chart, anytime the price of the company’s shares began to rise this year, it was hit with another wave of short sales that drove the price back down. By the end of last week, the total number of borrowed shares was reported to be about 8.5 million, or about 30 percent of the shares not held by company executives or entities they control. That level of short interest is unusual. It’s also suspicious — so much so that at one point this summer, shareholders could earn a 34 percent return by lending their stock to the shorts just for one month. Based on filings by brokerage firms, Northwest Bio estimates that, in addition to the 8.5 million reported short shares, there are as many as 4 million short “phantom” shares created by the “naked” transactions.
In late July, CREW’s executive director, Melanie Sloan, asked the Securities and Exchange Commission to investigate market manipulation of Northwest Bio’s stock. (Sloan told me her organization has never been contacted by the company and has no connection to its executives, investors or directors.)
In her letter, Sloan called particular attention to Adam Feuerstein, a biotech reporter whose relentlessly negative blog posts for thestreet.com this year have not only been filled with exaggeration, mischaracterization and half-truths, but curiously have also coincided with the spikes in short trading.
On March 11, for example, the day that German regulators announced their approval and Northwest Bio’s stock broke through $10, Feuerstein was quick to weigh in with a story that the company had withheld the news for two weeks to use it to divert attention from the fact that it had failed to deliver an interim report on the results of its Phase III trial back in the United States. As the chairman of the independent committee overseeing the trial later pointed out, there was no interim study and, by protocol, the company would have been prevented from seeing it even if there were one. As for that delay in getting out the good news, the company’s perfectly reasonable explanation was that it needed time to have the German notification translated into English and checked by the Germans.
The next month, on April 3, the headline on Feuerstein’s post was that Northwest Bio acknowledged that the FDA might throw out results of its Phase III study. It sounds pretty ominous. But all that really happened was that the company, in its annual report filed with the SEC, included that possibility in the long list of risks that investors should take into consideration, just as any company in the midst of a Phase III trial would have to do.
Or consider Feuerstein’s posts in May and June concerning a presentation by Northwest Bio’s chief executive, Linda Powers, at the big annual cancer research conference, in which she described how one patient had responded to the company’s therapy.
In both columns, Feuerstein expressed outrage that a drug company would exploit the suffering of patients for commercial gain (imagine that!) by selectively releasing results from a Phase I/II trial. He quoted Dr. Aman Buzdar, the head of clinical research at MD Anderson Cancer Center, the lead hospital for the Northwest Bios trial, criticizing the company for taking the “unusual and inappropriate” step of releasing such information. If Buzdar had first checked with his colleagues, however, he would have found that two of them had recently appeared in a National Geographic documentary focused on just such interim results from a pancreatic cancer patient. And, as CREW noted in its letter to the SEC, Buzdar himself made positive comments at a 1999 conference about a breast cancer drug he was testing that was still in clinical trials.
Then last week Feuerstein declared that the approval by London was really a “non-news event” because only one other company had applied for a similar approval since the program was launched in April. It was all just a smokescreen, he explained, to divert attention from the unfavorable terms on which Northwest Bio had recently raised another $27 million from investors in a hostile funding environment — a hostile funding environment, we should note, that Feuerstein himself had helped to create.
Feuerstein declined to speak to me last week, but his editor said she was sticking by her “dynamic” reporter. When I asked whether Feuerstein had been in contact with the shorts, she would only say that he was in touch with a wide range of investors. Using thestreet.com’s journalistic standards, the headline on that might be: “Biotech reporter concedes he may be exchanging information with shorts.”
I have no idea whether Northwest Bio’s immunizations work or whether it will become the billion dollar company that Powers says it could be. What I do know is that given the choice between allowing innovative companies to develop promising products that could save thousands of lives, or allowing Wall Street wise guys to use sleazy tactics to manipulate share prices for short-term profit, I’m siding with the companies. Maybe it’s time for the Justice Department and the Securities and Exchange Commission to be siding with them as well.
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Steven Pearlstein is a Post business and economics writer. He is also Robinson Professor of Public Affairs at George Mason University. Follow @StevePearlstein
Reminder what a real journalist article looks like. Imho
nice post etienne, we know LP has a plan, we are in phase II. Dr.Liau is gonna get validated with Phase III results.
good one sojourner, who should we believe a narcissistic political science major? or World Renown Neurosurgeon Dr.Linda Liau M.D., Ph.D., MBA head of UCLA Neurosurgery, Oh forgot we were talking about grapefruit juice, bathroom locations, dump fire trucks oh yeah AF is an expert on those things. A 2 year old or a grown up? Who do you believe?
Lol, we will have a group hug!
senti, so excited for X-mas in the spring! Hopefully we get publication, Dr.Liau gets validation she deserves,approval & patients finally get the vaccine covered by Insurance. We can move on to Direct trials with partnerships. I agree with you that shorts have been trying to get the trial unblinded early to decrease the chances of success for an accurate trial read out. Pressuring NWBO for information they did not have or could not share without biasing the trial. Good thing they stayed on course and true to their purpose.
Thanks senti, Mr.AF never quotes Dr.Liau or number of survivors??? You'd think he would go to the real source instead of these Dr.s that have no idea about the DC-Vax Trial? I guess AF does not think much about her opinion given she is one of the World's LEADING EXPERTs in NGBM? Well it is Mr.AF's job to ignore the FACTS.
YUP, Dr.Liau stated 25% Ngbm patients OS 5 Years or greater with DC-Vax L! She is the PI. Lawsuit Dismissed NO IA ever conducted period. ONLY Blinded Data Analysis. IMHO. 2018 is gonna be great! King of Cancers is going DOWN!
thanks IkeEsq, Direct & CI for all tumors? you should forward to Dr.Liau & LP. Why not Direct for all operable and inoperable tumors??? Worked so well for the inoperable Solid tumors, especially Sarcomas, why would they not try it for prevention in operable tumors for spread and re-occurance?
You truly feel Dr.Liau has misled us stating 25% of Ngbm patients can obtain 5 years or greater of OS with DC-Vax L? (possibly a cure?) do you feel misled by 84 PFS patients as of Feb. 2017? 2-1 Vaccine to Placebo. I feel pretty good myself about being misled by Dr.Liau and NWBO. imho sorry if I hurt your feelings. repeatedly stating trial failure and hiding of unblinded results does not make it true. Dr.Liau has stated she is still blinded and she is the Principle Investigator.