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I,for one, would say that your post would indicate you are a bright boy!
Merck actually announced positive Phase III results for sotatercept. It was upgraded today....
"Should be available before long" at 16:40
Tomorrow, October 5th marks 2 years since the announcement of Phase III data lock.
Make of that what you will. For me, there have been enough "bread crumbs" dropped along the way that make this stock completely de-risked. I await a sequence of announcements very shortly that will make history.
Given the current terrible state of the financial markets and the economy..... after the JA completely de-risks NWBO....when the UK grants RA and forces the FDA's hand....when manufacturing approval is received...I cannot imagine how much money will flock to NWBO in an attempt to quickly recoup losses from other investments. It's a huge win-win. Invest in a new standard of care for cancer and ride the share price increase to revalue your portfolio.The FOMO will be unbelievable. IMO
Hoffmann...IMO...."The short trades will take a big hit when PRs start to roll"....will only happen if the company takes some proactive actions to tie their hands...such as some kind of legal action or threat thereof. Otherwise they will continue their nefarious ways. They have zero regard for the truth, no matter how game changing it might be.
18 shares pre-market??? LOL! and WTF? why would someone spend $12 plus any fees unless it's a signal of some sort. The games people play.
After all these years it appears to me there is only one question left to answer. it is not if, but when. What is the timeline? The journal article, regulatory approval (UK first), manufacturing approval and a buyout (because of management's ages) are all a virtual certainty. The only uncertainty is WHEN! Everything else is white noise and should be paid no attention. IMO
President Biden is about to talk about his Cancer Moonshot proposal. NWBO and Dr. Linda Liau have been working for decades to create the next SOC for solid tumor cancers and this President will try to take credit for it when it happens.......mark my words.
Thanks Lykiri... Unfortunately, I wonder if everything gets cancelled because of the passing of the Queen.
Which King's College is hosting Dr. Ashkan tomorrow....please?
The share price is pathetic .
The volume is pathetic.
The company's timeline is pathetic.
The science is a GAME CHANGER!
IF YOU BELIEVE IN DCVAX AS I DO, EVERYTHING WILL BE FINE!
CHILL....
If the share price increases as fast as my ignore list is increasing, we will be in very good shape......soon.
10Q after hours today?
Absolutely correct. They did the least they could do to avoid legal action!
While I'm not exactly an expert on these things, it smells to me as if these C shares are going to be part of a post journal publication, JV/partnership/ deal. In my opinion, this is not about raising money to keep the lights on.
Who and why would anyone buy 3 shares pre-market unless it's a signal?
Without news we will continue to be manipulated with 100 share trades. Let it run a few pennies....drive it back down and whack it at the close. Rinse and repeat. I cannot wait for these people to get their comeuppance. And I hope it's as painful as possible.
The pessimist sees the difficulties in every opportunity, while an optimist
sees the opportunities in every difficulty.This is a choice one makes and then uses words to justify their perspective.
Every single excruciatingly frustrating day of no news and no journal article means we are one day closer. That perspective is the only way I can deal with this.
Be prepared... it's coming !
June 19th is Juneteenth a new national holiday. This year it's celebrated on Monday June 20th. Markets are closed.
Whatever PR firm GSK hired to hype its rectal cancer immunotherapy, sure got the job done. Headlines were over the top and even though when you dig deeper and realize the specifics are much more nuanced and limited, it's the headlines that people react to. NWBO would do well to study this so they can get the publicity that DCVAX-L deserves. My fears are that the PR surrounding the journal article (whenever it comes out) will be muted, reserved and unexciting. Science without salesmanship will not get the price where it deserves to be.
Is June 8th the deadline( minimum 10 days in Delaware) for ASM proxy notifications if the ASM is to be held on time?
The only thing that happened at ASCO was that the bread crumbs the company has been dropping to let us know where things stand, have turned into loaves of bread. Unfortunately, given the embargo, nothing permanently positive will happen to the share price until we get the journal article . Absent a PR of the journal date, we will know when it's coming from unexpected volume increases signaling a leak of information. Until then, we wait and wait and wait .
Margaret, I'll answer your question. I am here as a survivor of colon cancer and because of losing a family member to GBM as well. Some days I'm here because I want to make money and other days my priority is the eventual eradication of cancer.
Today I believe both are possible.
Numbers are numbers. Data are data. When I see 2 + 2 it equals 4 every time . Some here would have you believe 2 + 2 = 3. No matter how loudly you scream and yell, 2 + 2 DOES NOT AND WILL NOT EVER equal 3.
The next shoe to fall will be complete TLD and the peer reviewed journal article. Following that,I am on record with my opinion that NWBO will get approval in the UK first and hopefully, that approval will force the FDA and others to speed up their reviews and hopefully, approvals.
Monday should be very interesting. I try my best to not wish ill or pain on anyone so, I hope the evil doers are well stocked with vaseline.
I believe the presentation is from 3-4 CT which is 4-5 ET
Biotech researcher.... do some research. In the meantime you're ignored.
Dr. B , you are right that data wins in the end. However, I will wager that no matter how good the final data is, AF will create out of thin air some negative issues to diminish this trial. The company needs to be prepared for this and either have a plan to pre-empt his lies, or a legal team ready to react and deal with him.
I am in agreement with your key points and believe that the trial was a spectacular success. Understanding how pseudoprogression renders progression free survival meaningless, that median overall survival is the gold standard endpoint for oncology trials and that FDA in some situations may allow the use of external controls are critical to understanding why the trial was such a success. You do a good job on this.
The stock decline on May 10, 2022 was meaningfully abetted by Adam Feuerstein’s article on Stat News entitled “It took years, but the failure of Northwest Bio’s brain cancer vaccine is now in the open.” His report was widely circulated to news outlets, some of whom reiterated Feuerstein’s demonstrably false claims that the trial had failed. Feuerstein appears to have been a catalyst in the stock decline.
The number of market makers for Northwest is usually about 6, but on May 10, there were 13 market makers; more market makers facilitates shorting. Hmmm. There were 77 million shares traded on May 10 and I believe that based on past experience that 80% could have been counterfeit shares (created through naked shorting).
In this comment, I present Feuerstein’s report in full and my critique of his demonstrably false assertion that the trial failed. I have not edited the Feuerstein report in any way. However, I do add editorial comments at certain points to interject actual facts into what I consider to be his work of fiction. I am stunned at how he grossly misrepresented the results of the trial as presented at the New York Academy of Sciences on May 10. His comments are frankly childlike and totally misrepresent the data that was presented.
NYAS Presentation on DCVax-L Phase 3 Trial Was Extremely Positive
The NYAS presentation can be viewed on You Tube at this link. virtualtrials.org/... Some of the key data slides are as follows:
Slide 29: Kaplan Meier analysis shows that DCVax-L met median overall survival primary endpoint in newly diagnosed GBM with a strong p value of less than 0.002.
Slide 30 Survival tail in ndGBM showed 13.0% of patients alive at five years versus 5.7% in control group. This is every bit as impressive as survival tails for the checkpoint inhibitors in recurrent non-small cell lung cancer and recurrent melanoma, cancers which are roughly equivalent to glioblastoma in terms of survival.
Slide 39: Kaplan Meier analysis shows that DCVax-L met median overall survival primary endpoint in newly diagnosed GBM with a strong p value of less than 0.001.
Slide 40:The survival tail for DCVax-L in recurrent GBM showed that at 30 months 11.1% of GBM patients were alive versus 5.1% in the control arm.
It is important to understand that the actual endpoints of the trial were median overall survival. These are described on the government website ClinTrials.gov. Here is the link. clinicaltrials.gov/... The phase 3 trial was designed to evaluate the impact on survival time, as well as safety, in patients following treatment with DCVax(R)-L, an immunotherapy treatment for GBM. The control arm was based on 1,366 patients who received standard of care in several glioblastoma trials that ran concurrently with the DCVax-L phase 3 trial. FDA officials in the oncology division have recently signaled that the use of external controls may be acceptable in some cases. See this link. smithonstocks.com/...
According to ClinTrials.gov. the primary study endpoint is OS (overall survival) compared to external controls in newly diagnosed glioblastoma, and the first secondary endpoint is OS compared to external controls in recurrent glioblastoma. In judging how dishonest the Feuerstein article is, it is critical to understand that progression free survival is not part of the statistical analysis plan. It is not even a secondary endpoint. However, Feuerstein claims that the trial was a failure because it did not show statistical significance on progression free survival. This is just a blatantly false representation of results.
The Feuerstein Report Blatantly Misrepresents Actual Results as Presented at NYAS
Here is Feuerstein’s full article with my comments interspersed.
It took years, but the failure of Northwest Bio’s brain cancer vaccine is now in the open
By Adam Feuerstein May 10, 2022
After years of delays and excuses, Northwest Biotherapeutics finally disclosed on Tuesday the final results from a late-stage clinical trial of its personalized cancer vaccine administered to patients with brain tumors. The treatment’s data are as bad as expected — performing worse than a placebo.
Patients administered the Northwest Bio treatment, called DCVax, went a median 6.2 months without their brain tumors returning compared to a median of 7.6 months for patients offered a placebo.
(SmithOnStocks comment: Progression free survival was not the endpoint. The endpoint was median overall survival as previously described.)
Overall, patients treated with DCVax had a 10% higher risk of tumor progression compared to placebo — an outcome that is the antithesis of what’s required from any effective cancer treatment.
(SmithOnStocks comment; This is meaningless).
DCVax is a cancer vaccine, meaning it’s designed to stimulate the body’s own immune system to find and kill cancer cells. Some immunotherapies have been shown to prolong survival despite minimal effect on tumor shrinkage. That wasn’t the case with DCVax. The Northwest Bio study was also designed to measure and compare the overall survival of DCVax and placebo patients, but the company chose not to disclose those survival data on Tuesday — for reasons that are now clear.
(SmithOnStocks comment; The presentation clearly noted that the trial reached the primary endpoint of median overall survival in newly diagnosed glioblastoma multiforme with a stunning p value of <0.002. It also reached the secondary endpoint of median overall survival in recurrent glioblastoma multiforme with a p-value of <0.001. Feuerstein omits any mention of this and actually claims that survival data was not presented.)
The Phase 3 study enrolled 331 patients with newly diagnosed glioblastoma, an aggressive form of brain cancer. DCVax was administered to 232 patients; 99 patients received a placebo. The final data were presented at a cancer immunotherapy meeting sponsored by the New York Academy of Sciences.
Nineteen months have passed since Northwest Bio announced that the DCVax study had reached “data lock” — a standard step in the closure of a clinical trial that ordinarily leads quickly to data analysis and the announcement of the study outcome. “We are excited to be so close to the finish line now, after such a long road,” said Linda Powers, Northwest Bio’s CEO, in an Oct. 5, 2020, press release.
Instead of acknowledging the futility of its brain tumor treatment, Northwest Bio used the long interregnum to concoct a false, alternative reality in which the study was successful and DCVax extended the lives of patients.
To do this, the company discarded the overall survival data from the 99 patients randomized to treatment with a placebo. Those original, prespecified data were thrown out, and replaced on a post-hoc basis with survival data collected from 1,366 patients who participated in five entirely separate and previously completed clinical trials.
(SmithOnStocks comment: The 99 patients randomized to placebo were not thrown away. Those who progressed were categorized as having recurrent GBM. After progression, they were crossed over to DCVax-L and they formed the basis for an analysis of median overall survival in recurrent glioblastoma multiforme. The p value for this group was stunning at <0.001.)
When the 233 patients treated with DCVax were compared to the 1,366 patients taken from “external controls,” Northwest Bio said it found a 20% relative reduction in the risk of death. At the median, the DCVax patients lived for 19.3 months compared to 16.5 months for the make-believe group of control patients.(SmithOnStocks comment: Feuerstein mocks the use of external controls. However, key employees in the oncology section of the FDA recently published an article in which they stated that in some cases, it is appropriate to use external controls as a control arm. See my article Northwest Biotherapeutics: FDA Statement Regarding Use of External Controls in Clinical Trials is a Huge Positive at this link.
smithonstocks.com/...
Northwest was very careful to present results for their external controls in accordance to suggestions made by this FDA officials.)
When you throw a dart against a wall first, and then paint a bullseye, it’s really easy to declare a win. It’s not, of course. It’s cheating. And that’s what Northwest Bio did with the analysis of its DCVax study.
(SmithOnStocks comment: Seventy clinical trial investigators involved in the trial attested to the accuracy of the results. Feuerstein with his strong political science background maintains they are all wrong. He is delusional.)
Northwest Bio shares plunged 70% on Tuesday once the DCVax presentation concluded. After a brief rise to around $2 per share in the run-up to Tuesday’s event, the stock is now trading again well below a buck. (SmithOnStocks comment: The only negative news on May 10 was the article by Feuerstein which was fed to news outlets and Wall Street trading desks. Feuerstein is taking credit and bragging about how he was able to crush the stock price)
No one was fooled.
(SmithOnStocks comment: No one is fooled by Adam Feuerstein.)
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Here you go.
Presentation at the New York Academy of Sciences on Final Results of Phase 3 DCVax-L Trial Showing Impressive Efficacy (Part 4) If The Phase 3 Data Is So Good, Why Hasn’t Northwest Issued A Press Release?
POSTED by LARRY SMITH on MAY 12, 2022 • (0)
I have been getting a lot of questions on why Northwest Biotherapeutics has not issued press releases based on the presentation at the New York Academy of Sciences on the successful phase 3 trial of DCVax-L in both newly diagnosed and recurrent glioblastoma multiforme. Management has said nothing about this, but here is my speculation. Northwest has repeatedly stated that it wants to get the trial results published in a peer reviewed medical journal. Most, if not all, journals will not publish a manuscript on a trial if the company has previously released results through press releases. At this point, you are probably saying wait a minute, the data presented at the New York Academy is already widely distributed in the public domain. I think that the answer to this paradox is that some (most) medical journals do not regard a presentation at a peer reviewed, scientific conference like the New York Academy in the same way as they would a press release by Northwest.
Here is my take. Northwest has been pursuing publication in a peer reviewed medical journal. I do not think they would have gone forward with the academy presentation if they felt that this would preclude publication. I can only speculate that they had good reason to believe that presentation at the academy would not jeopardize a publication in a peer reviewed journal. However, they would likely and rightly feel that any company related press releases might preclude publication.
If it were the case that NWBO had no hope of publishing results in a peer reviewed medical journal, they would almost certainly be trumpeting the highly positive results in press releases and through an active outreach to media. Their silence gives me confidence in my assertion that they are endeavoring to get the results published in a peer reviewed medical journal. If this is so, I have no idea on the time when they will know about the decision of the medical journal(s) and inform investors.
I know that it has been incredibly tough to finally see the top line data and to have it meet our most positive expectations only to see the wolfpack successfully attack the stock in an effort to convince investors that the trial results were disappointing. I know I am. However, I am heartened that we now know the data. Our day is coming. I see autologous dendritic T-cell therapy as potentially more important than the CAR-T therapy. It more directly targets tumor antigens associated with an individual's tumor and is much, much safer and easier to administer. More on this to come.
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I really hope that we get the journal article and full TLD before ASCO. If, for whatever reason, ASCO comes and goes with the company still under a gag order from the journal.... it will be a bloodbath. If we DO get the journal and can freely talk about DCVax-L then ASCO will be a coming out party and there will be nothing AF or anyone else can do to subvert things. Just my opinion
Unfortunately, I don't see the updated primary outcomes having any positive effect on the share price without an accompanying PR stating such. Also a PR calling out the "evil doers" on their misrepresentations of the trial results. The fact that most on this board knows this information is great news is irrelevant . In fact, knowing the gig is close to being up, the shorts will attack one more time in my opinion. Until the company gets aggressive in this fight (journal or no journal) we are stuck.
Roughly 1.4 billion dollars of shareholder value lost since May 10 and not a word about it from the company.
From the Sound of Silence "Fools" said I, "You do not know
Silence like a cancer grows"
Absent getting the Journal article tomorrow or the the clinical trials website updating OS as primary endpoint, the least I want is this announcement from the company.
"We are aware of the many inaccurate and potentially libelous comments made about the May 10 NYAS presentation, and are pursuing all legal remedies against those involved."
I don't expect this to happen but I sure would like for them to show some fight back in this debacle.
Got this from DI
"We are working on all fronts to have what was presented last Tuesday to be
accurately reflected."
Here is what I've learned in the last month.
1. We have what might be a new standard of care for GBM
2. In time we might have a new standard of care for all solid cancer tumors.
3. If 1 & 2 are ever going to happen, this company will need to be partnered or sold
to someone who can actually handle this.
4. This current company structure cannot possibly take this to the end zone.
JTORENCE .... They had astro turf and the working theory is that turf was part of the problem. Also in KC
Magrit,
Excellent letter. You just left out the part.... "and if you don't correct your deceptive reporting, we'll sue your ass!"
It's time for the gloves to come off.