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Perhaps submission of the MAA application is the event they are waiting on to announce the ASM? It is not known whether the journal article will also drop within the next 30 days. But the MAA has a more definitive timeline and so could be the likely event holding up scheduling the ASM.
They will be assimilated. Resistance is futile.
Then, the PR also includes this:
An automated system for the fill and finish of DCVax-L product has also been delivered, installed, validated and qualified. "Fill and finish" is the final step of the process, after a batch of DCVax-L product has been manufactured, in which the batch is allocated into single doses in individual vials for cryopreservation and distribution.
Does that refer to Flaskworks? It is also DCVAX-L specific. So it would appear that they are also setting up for commercial manufaturing of DCVAX-L.
LOL. Good One.
Needed for marketing, etc. I think it is another bread crumb denoting confidence that DCVAX-L will get approval
Thanks.
What is iwasadiver's twitter handle? Thanks.
They actually use 'DCVax®'.
Check the spelling - it is not the account you are looking for..
As another poster stated: LP doesn't stick to coloring between the lines.
Thanks. I hope you are right - If calendar days, then July 15 is Day 150. Else, it is mid-September
Is that 150 business days or calendar days?
The breadcrumb trail.
Wouldn't the FDA have to set a PDUFA date for reviewing and providing approval? Or does that only apply to an NDA and not a BLA?
Unfortunately, it has done that a number of days in the last week or so - opened on an encouraging note, stays up for a while and is then walked down during the afternoon to even close red. The MMs are not ony manipulating the SP, but also investor emotions..
If you haven’t figured it by now, that is an impossibility
Per other posters on this board, Dr. Ashkan's pre-taped presentation was being screened at the booth. He covered additional information and it is available at Dr. Musella's virtualtrials.org website.
Need more of Dr. Ashkan in our PR NWBO lives somehow / someway. Need to get word out, and clearly he is good lead for job.
To the extent that data is available on the various segments of the trial patients, IMO, Flipper would have presented this board with in-depth analyses to rival quite a bit of what the journal article will provide.
I eagerly await the next exposition.
Per Ex: just need to be under 70 and have a total resection. [Conveniently ignoring that the NYAS slides showed that surprisingly, less than total resection and older patients did quite well.]
Per AF: Drink grapefruit juice.
BTW: is that 13% the treatment arm only or total for the trial. If just the treatment arm, then need to factor in the recurrent GBM from the crossover.
Do you plan to attend the Genentech sponsored STAT News event that includes the interview with Dr. Pazdur? Would be good to get a summary of that from some of the board members instead of AF's interpretation of what is discussed.
Hopefully, sooner rather than later.
By spreading lies amongst his 'fellow journalists' at ASCO and throwing doubt on the veraicty of the speakers and their presentation?
AF is a street fighter, plain and simple. As you can see - by (allegedly) threatening Dr. LL; threatening NYAS; reaching out to Dr. Toms' employer, Brown University (under the guise of verifying the twitter handle) for low-level intimidation - he will do whatever it takes to notch a win, whether he is right or wrong.
Flipper44:
Very interesting and thoughtful observations.
You should end your posts with 'Elementary, my dear Watson' .
And, especially with GBM where the brain tumors nearly always returns.
Then they must have told him to double down, because that appears to be the result.
I believe Hope4Patients was looking into filing a suit and asked others who had losses to contact him.
Issue 5, May 2022 as well as Supplement 3, May 2022 have been published.AOO Issues page.
Flipper's post from May 15:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=168865508
had this sentence in it:
On another completely different topic, I also find it interesting AOO seems to be reworking their publication to achieve a belated publication within the next week.
If I remember right, RANO criteria were being used by some to argue that it was progression, but as pseudoprogression became better recognized, I believe, iRANO was formulated in response to that knowledge to account for immunotherapy induced psPD.
The nuances that are deliberately ignored to make the bear case. Thanks for making that fine point.
This was Smith on Stocks's comment, on the Avisol Partners's SA article, posted on Sunday, May 22, 2022 at 7:39 am
Smith On Stocks
Today, 7:39 AM
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Purpose of This Comment
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.)
Bio - very well stated. I would even say, rigid formalism to chracterize the argument put forth as it does not allow for any evolution based on new knowledge and learned experiences.
Over the years I have noticed that the first go t arguent to deny any success is to state that 'that is not way it has been done' or 'it has never happened that way', etc.
Then when it does happen the way it was not supposed to, the next step is to invoke form over science and further obfuscate with cherry picked statistics and numbers.
Rinse and repeat with every event.
apwriter posted it.
AF on the phone all day w @UCLA libel legal team and his mystery sponsors. @statnews needs to lawyer up. No one Libels Dr Linda Liau by inferring fraud? AF went too far. Discovery w forensic accounting will be interesting. $nwbo #MOASS
— annie post (@apwriter) May 11, 2022
But that won't stop Stat News from asking leading questions - pretty much all the topics listed in that tweet have a bearing on this trial and they will try and trip him up. If his responses are very balanced, to avoid giving any hints about his thoughts on this trial, that can also will be spun as a negative.
That agenda seems stacked towards putting Pazdur between a rock and a hard place. The context for all of those topics is DCVAX data release and they will try and get him to either say there is no chance DCVAX gets approved or it can. If the latter, it is lights out for them but not sure Pazdur can say anything either way. So, then his neutrality will be spun by Stat.
Thanks Sojo. Always appreciate your charts, insights and 'steady as she goes' attitude.
I thought someone said it would be in the next couple of days.