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I'm surprised, after all this time, that you would believe claims made by NWBO in a press release.
I did warn you folks...
Larry Smith has written 66 blog posts about NWBO since 2012. In his second blog post on the company, published July 19, 2012, Smith called NWBO and DCVaX-L a "game changer."
I have written 58 articles and columns about NWBO since 2007 (really since 2011, since I only wrote one NWBO story between 2007 and 2011. In that first story in 2011, I wrote:
"I saw some bad stuff Monday and Tuesday. Topping the garbage list was Northwest Biotherapeutics ( NWBO.OB) -- easily the worst and most laughable presentation I saw at the conference. I almost fell off my chair when Northwest chief Linda Powers showed slides with Kaplan-Meyer survival curves demonstrating a "survival benefit" for the company's DCVax cancer immunotherapy over historical data culled from previously published clinical studies. Heck, Powers even attached a statistically significant p value to this pseudo-scientific nonsense. The entire Northwest presentation was appalling."
Larry should retire.
I never invested in Enron. Where the hell did that false rumor start?
I disagree. The wheels move slow at the SEC, but eventually, the enforcement branch will nab Linda Powers. Unfortunately, SEC corrective action won't take place until after NWBO goes belly up and everyone holding the stock loses all their money.
I was right.
To recap, back in April, many of you were jumping up and down with excitement about the prospect of a partnership between NWBO and either BMS or Merck.
I told you that there was no partnership between the companies. At best, there was likely to be an investigator-sponsored study in which DCVax would be combined with a PD-1.
You didn't believe me.
And so today, NWBO announced an investigator-sponsored study by a German hospital which will combine DCVax and pembrolizumab. The only thing I got wrong was the location of the investigator. Last April, it looked like UCLA would be running a study. This one is being done in Germany.
But wait, Adam! You're wrong because Merck is providing pembrolizumab for use in the trial. This means NWBO and Merck are collaborating!!!!
No, it doesn't. Merck routinely provides drug gratis to academic centers for clinical trials. That's what is happening here.
I waited to post here because I wanted to confirm with Merck.
Merck told me just minutes ago that the company's only involvement is providing pembrolizumab to the investigator in Germanys so he can run the trial. There is no partnership or collaboration with NWBO.
Sorry, guys...
Nasdaq has to approve the NWBO financing but has yet to do so, which why the deal is delayed. No word on when Nasdaq will make a decision.
The re-pricing of existing warrants from previous deals is the gating factor holding up the current financing, complicated by NWBO's previous violation of Nasdaq rules.
I know the identity of the investor. I'm not guessing, speculating or hearing second hand. I KNOW the investor. Guaranteed. 100%. Confirmed.
No, I will not tell you his name, except, it's not Woodford.
I know the identity of the person who bought the NWBO financing last week. It's my job to know these things, which is why I'm so damn good at my job.
He's not an investor, if you define the term as someone who believes in NWBO and desires to hold the stock long as it (hopefully) appreciates.
That's not this guy's game plan or motivation at all.
He bought the NWBO deal because he was able to dictate and receive incredibly favorable terms from Linda. She's desperate to raise money, so she was willing to sell him 5 million shares of NWBO priced at a 30% discount to the market. The buyer would normally ask for warrants, but the pricing discount was so large that he didn't need or want them.
Buying stock at 38 cents per share is essentially a foolproof way to print money. The buyer simply resells - flips -- the purchased stock back into the market for an instant profit. Even with NWBO trading down to the mid 40 cent range, he's still making money.
When MD1225 buys more NWBO, he'll probably buy it from the guy who bought the NWBO deal.
There is no white knight investor coming to save NWBO, just more vultures circling overhead, happy to pick at the corpse.
NWBO should develop a drug for schizophrenia....
Because Linda is arguing with herself.
Cognate (Linda) complains about late and delinquent payments from NWBO (Linda), so NWBO (Linda) talks to Cognate (Linda) and reaches an agreement whereby NWBO (Linda) has to start paying Cognate (Linda) on time.
Classic.
The SS NWBO is sinking but Captain Linda is already in the lifeboat by herself, rowing away.
https://www.sec.gov/Archives/edgar/data/1072379/000114420416128637/v450788_8-k.htm
Wowza!
Chris, I thought you were bullish on NWBO?
If NWBO announces the passing of 248 PFS events in the phase III study without disclosing the outcome, the study failed.
PFS is the primary endpoint of the phase 3 study. When the primary endpoint fails, there is no valid statistical test for secondary endpoints. NWBO cannot fail on PFS and succeed on OS in the phase III study. Any claim otherwise will be laughed out of the FDA.
Now, given Linda's history of misleading statements about DCVax and the phase 3 study, I'm sure she'll try to pull of another stunt. That will fun to watch.
Maybe the games are just getting started. I hope so. There's no fun like writing about NWBO fun.
Austin - On Monday, NWBO will be presenting an update on this slide from Wednesday's presentation:
The new data will show a correlation between breathing and survival of DCVax-Direct patients. NWBO has discovered that patients still breathing are living longer than patients who are not. Amazing stuff.
Thanks, Austin.
Wrong link. You want to look here:
http://www.loncarindex.com/#!loncar-cancer-immunotherapy-index-faq/c1lpm
How companies are chosen for the Loncar Index and ETF.
It's largely market-cap based within a cancer immunotherapy framework.
Brad and his team didn't choose NWBO bc they believed in DCVax. NWBO was included in the initial index because of the market cap at that time. At the first re-weighting of the index, NWBO was dropped because of the market cap.
by the way, I'm good friends with Brad. He doesn't believe in NWBO.
Brad Loncar doesn't pick the stocks included in his index. How do you not know that?
I lost money in Enron? Nope.
I don't know who started this crazy, false rumor but I admire the creativity.
Merck and Bristol aren't negotiating anything with NWBO, so there's no confidentiality to keep.
So, when I asked Merck and Bristol, "Are you collaborating or partnering with Northwest Bio...?", the answer from both companies was "No, we are not."
No waffling there.
Except...
I already told you Merck and Bristol-Myers Squibb are not collaborating with NWBO on clinical studies.
I know this because I asked Merck and Bristol. Both companies told me no collaboration, no partnership, with NWBO.
But you keep dreaming!
Short of Cash, Northwest Bio Flirts With Insolvency
https://www.thestreet.com/story/13672780/1/short-of-cash-northwest-bio-flirts-with-insolvency.html
My latest story on NWBO. Enjoy!
NWBO is on the cusp of financial insolvency, Its phase 3 study has been shut down for almost one year, and you want to ask me about Buzdar?
Wow, talk about whistling past the graveyard!
Sure, why not.
Was it a phonecall from you to him?
Yes. I was put in touch with Dr. Buzdar by MD Anderson's public affairs officer.
Did you record the call as an aide memoire, so that any quote would be accurate? If you retained a recording, would you mind posting a transcript of the call on the board?
No, I did not record the interview with Buzdar. The quote was accurate. Neither Dr. Buzdar or MD Anderson has said otherwise.
Did he say that the conversation was on the record, and consent to you quoting him?
Yes and yes.
Did he say that he was speaking on behalf of MD Anderson?
Yes, Dr. Buzdar was vice president of clinical research at MD Anderson. He was speaking to me as a representative of the academic cancer hospital. As I noted above, I was put in touch with Dr. Buzdar by MD Anderson.
Did you know that he was in breach of MD Anderson's policies and procedures in speaking to you?
If MD Anderson helped set up my interview with Dr. Buzdar, how would he be violating the center's policies and procedures?
Maybe you missed this statement issued by MD Anderson following the publication of my story:
https://www.mdanderson.org/newsroom/2014/06/statement-regarding-release-of-data-prior-to-study-conclusion.html
How did he know anything about the Direct trial and on what basis would he have had any right to said knowledge?
Because he works at MD Anderson as the vice president of clinical research. The DCVax Direct study was conducted at MD Anderson.
Did you know there are many examples of MD Anderson (or a trial sponsor)
releasing preliminary trial data?
No.
Is NWBO financially insolvent (out of cash)?
Per the latest 10-Q...
The company ended the second quarter with $2.1 million in cash on hand.
On July 4, the company raised an additional $3.3 million.
That's $5.4 million cash on hand at the beginning of July.
NWBO is burning $5 million per month, per the latest 10Q, and that's after sharply reducing operating expenses.
We're now in the middle of August. The company's cash should be gone by now, or almost gone.
I emailed Les to ask him for an update on the company's financial status but he hasn't responded yet. There's a guy who posts on the this board who claims to speak with Les all the time. Maybe he can ask Les if NWBO is still in business because the cash math says they're either shut down or within days of shutting down.
By the way, it's almost one year since the DCVax ph3 study was placed on the "interim" patient screening halt. No resolution. No explanation and NWBO's stock has lost 95% of its value.
Pyr is right about NWBO, despite getting CYTR wrong.
He should have listened to me!
Good journalists cultivate reliable sources capable of providing information. I'm referring to private, closely held information not normally made public, the kind of stuff companies don't want made public.
I'm one of those good journalists.
I'm not going to tell you my source(s).
No, I don't rely on hackers or moles. It's people talking to other people.
So, what I told you about NWBO's last financing was true.
Have a nice weekend.
Who is AFraudstein?
He sounds like a very powerful, influential guy.
Full enrollment for the phase 3 study is 348 patients.
You believe NWBO has enrolled 338 or 347 patients but for some reason is only disclosing publicly enrollment of "over 300"? And that for almost one year, the company has enrolled more patients but is still telling investors that enrollment is only "over 300"?
Hmm... Okay. Good luck with that.
If NWBO was at 347, there wouldn't be a study halt. The company would issue a PR stating enrollment into the study was complete.
But yes, I know.. NWBO bulls cling to the belief that Linda is super sneaky and doesn't want anyone to know the study is fully enrolled. If the wolf pack found out the study was fully enrolled, they'd start killing off patients to foil the outcome.
I do love this message board for the entertainment value.
Probably the best post ever on this message board. You truly capture it.
I'm sorry. Each time you've asked me the enrollment question, I was unable to respond because my allotment of three daily posts on this board were already used up. And then I forgot to follow up.
You ask:
"In your opinion how many patients are currently enrolled and being treated per the protocol in NWBO's phase 3 trial?"
I don't know because NWBO has not provided an enrollment update for quite some time. Clearly, however, the halt on patient screening has delayed the study significantly.
Here's what NWBO states in its most recent SEC filing tied to this week's offering. This is the same language in the most recent 10-K as well:
"Our current Phase III 348-patient clinical trial of DCVax-L for GBM is our first late stage trial. We may be required to conduct additional late stage trials with DCVax-L for GBM before we can obtain product approval. This would substantially delay our commercialization. In addition, our Phase III trial of DCVax-L is on a partial clinical hold for new screening for enrollment. We do not know what will happen with this partial hold. Although we have over 300 of the planned 348 patients already enrolled in this trial, and they have continued to be treated without interruption, we may not be released from the screening hold and may not be able to complete the planned enrollment in this trial. There is also some possibility that changes requested by the FDA and/or other regulators could complicate the application process for product approval. In addition, a rapidly growing number of products are under development for brain cancer, including immunotherapies such as checkpoint inhibitor drugs and T cell based therapies, and some (e.g., NovoCure’s device) have been approved in the U.S. It is possible that the standard of care for brain cancer could change while our Phase III trial is still under way. This could necessitate further clinical trials with our DCVax-L product candidate for brain cancer."
Emphasis mine.
So, as of this week, NWBO says "over 300" patients enrolled. Last August, when the study halt was first disclosed, NWBO said "over 300" patients were enrolled.
So, the conclusion you can reach is that no new patients have been enrolled into the study since the halt went into effect last August.
It's impossible to answer the second part of your question -- how many patients are currently being treated. I have no idea how many enrolled patients have died or dropped out of the study. Again, NWBO has not provided any public update on the status of the trial. We have no idea how far away or close they are to reaching the number of PFS events necessary to conduct the final analysis.
I hope this answers your question. Sorry for not responding sooner.
I saw but didn't read Steve's research report on CYTR posted on Seeking Alpha. I know he believes the aldoxorubicin ph3 study will be a success. I disagree. I think the study will fail.
I don't have any "feelings" about Steve's CYTR call. Did he ridicule me? That doesn't seem like his style but it doesn't really matter. I don't get worked up about people with opposing views on stocks. There's a bull and bear thesis on every stock. That's the way the market works.
If Steve is right about CYTR, i'll congratulate him on making a good call and I'll acknowledge my error. I'm pretty sure he'll do the same if the aldoxorubicin study fails.
I did see that Steve asked me to acknowledge that even with my bearish call on CYTR, it's still better than NWBO.
I see it differently, CYTR = NWBO in that they're both worthless in the end. I don't know how long it will take for both stocks to reach terminal zero, but they will both get there. Perhaps NWBO sooner than CYTR given the former's precarious financial position. This week's financing was truly desperate. NWBO went back to the market on the 45th day and last day of its standstill agreement with the investor in the previous deal. The company was so short of cash that it, literally, could not wait a single day before raising more.
The buyers of this week's deal were PIPE funds, which means they've already sold the stock they bought. They only care about the free warrants.
A great plan, Steve, except...
The CYTR aldoxorubicin phase 3 study is going to fail.
That sort of sucks the wind out of your happy ending for NWBO longs.
Here is an (oldish) NY Times story discussing materiality when it comes public company disclosures:
http://dealbook.nytimes.com/2011/04/05/in-corporate-disclosure-a-murky-definition-of-material/
Here is an (oldish) NY Times story discussing materiality when it comes public company disclosures:
http://dealbook.nytimes.com/2011/04/05/in-corporate-disclosure-a-murky-definition-of-material/
You are co-mingling and confusing FDA law with securities law.
The FDA, by law, will not disclose information contained in a sponsor's BLA. Generally speaking, communications between the agency and the sponsor are privileged and confidential.
In practical terms, if you call the FDA and ask, "Did NWBO file a BLA?" The FDA will say, "We can't tell you."
The FDA discloses drug approvals. We've all seen press releases issued from the FDA's media department when a new drug is approved. But, the FDA will not comment publicly when a drug is rejected (Complete response letter is issued.) That information must be disseminated by the company.
There are other examples where FDA discloses information regardless of whether or not a company wants that information made public. Examples: Warning letters, Dear Doctor safety letters, updates to the Orange Book, etc.
So, you are sorta correct when you say, "Because FDA is under a strict obligation to protect such company's material information until the company CHOOSES to reveal it."
But there are exceptions.
Now, publicly traded companies must abide by U.S. securities laws, which among other things, requires prompt public disclosure of material (stock moving) information.
For any biotech company the size of NWBO, filing a BLA is a material event under any definition. If NWBO had filed a BLA, the company would have disclosed with a press release and/or an 8-k filing.
The definition of materiality often depends on the size of the company. Think about this way, if Pfizer files a BLA for a small niche product, it may not disclose because that news isn't really material to the stock.
The same cannot be said for a tiny company like NWBO. DCVax is the most important product for the company. If a BLA was filed, it would be defined as a material event and disclosed.
I can't think of a single example where any biotech company did not issue a press release or file an 8K upon filing a BLA with the FDA.
That we're actually having this debate underscores once again NWBO's dismal track record for transparency. These questions should not need to be asked. "Normal" well run biotech companies do not keep their shareholders in the dark about important developments.
I read the post and laughed out loud. Literally.
Let's dissect:
"No problem at all the patients whom made the cut off "well over 300" per the company, my guess 340 already have three years worth of DCVAXL made."
Full enrollment in the study is 348 patients, so this guy is claiming the study is basically fully enrolled? If that's true, there would be no reason to announce a halt to patient screening. NWBO would just say the study was fully enrolled.
The screening halt clearly is because the company and Dr Liau saw how well all the patients were doing and realized for approval commercialization scale needed to be in place. That is clearly what has been going on from all the posts pertaining to buildout over the past months.
You guys always claim NWBO is blinded to the data from the phase 3 study, but now this guy is saying NWBO and Dr. Liau know the patients are doing great? Hmm... so much for the legitimacy of the double blind trial design!
By the way, commercialization and/or manufacturing scale-up are not factors in the outcome of a clinical study. A company would never halt a study early simply because it needs to boost manufacturing capacity. That would be done outside the conduct of a clinical trial, if necessary.
Linda is going after AA maybe for all Gliomastoma patients but certainly for mesenchymal subgroup. But before this can be granted the FDA needs to know commercialization capacity can be met.
Linda cannot "go after AA." NWBO can file a BLA for DCVax-L or not. NWBO can request priority review. AA, or accelerated approval, is a regulatory review based on a surrogate endpoint deemed likely to correlate with clinical benefit. There is no surrogate endpoint in the NWBO ph3 trial.
Oh, and your mesenchymal subgroup conjecture is pure fantasy because it's a retrospectively defined subgroup of patients.
Anything else you want to blather on about?
Linda Powers, with all her self dealings and lack of transparency, treats NWBO as if it was a private company. But NWBO is a public company. This means NWBO must abide by securities laws governing the conduct of publicly traded companies.
This means that NWBO is required to make prompt public disclosures of material news and information.
NWBO has not submitted a BLA of any kind. Had NWBO submitted a BLA of any kind, the company could not keep it secret. That's a material, disclosable event.
NWBO has also not completed the phase 3 study in secret. Again, completing the study, having data in hand, would be material information requiring disclosure.
I know many of you love to conjure up ways in which NWBO is different or special from its biotech peers, but it's not. The same rules apply. Look around. Companies routinely disclose clinical and regulatory milestones like the completion of trial enrollment, interim or final analysis triggers, actual top-line data results (!!!) and submissions of BLAs or NDAs to the FDA.
NWBO has not done any of these things because none of these events have taken place yet.
NWBO is almost out of cash again. The stock is sitting a penny above its all-time low.
I enjoy reading this message board.
With almost no exceptions over the past 12-18 months, NWBO executives have only spoken publicly at pay-for-play industry networking conferences. NWBO pays to sponsor the event and in return, an executive (Linda Powers) is given a presentation slot.
NWBO has not presented clinical data at a "real" i.e. peer-reviewed medical meeting in a long time. For instance, the last abstract submitted and accepted at ASCO was 2 or 3 years ago. Paying to speak in the exhibit hall, which NWBO did last year, does not count.
NWBO does not hold quarterly conference calls for shareholders. The company rarely presents at healthcare investor conferences.
What do you believe will be the conclusion of the investigation into the allegations contained in the P5 report ?
The investigation will find no wrongdoing on the part of Linda Powers or anyone else connected to NWBO. This will be a lie and a coverup, of course, but that's the outcome NWBO paid for. You don't actually believe the investigation is independent, do you?
Do you also believe everything you have previously written about NWBO is still fact?
Yes.
Do you think we will see arrests and charges brought against anyone guilty of manipulating the share price or indeed guilty of helping to manipulate the stock ?
If the context of your question is the frequently shouted accusations of short-selling manipulation, the answer is no, there will be no arrests or charges. Why? Because these accusations are false. They're fantasies.
With that said, there is ample justification for a real, external investigation into NWBO's business practices, particularly the constant and exorbitant flow of money from shareholders, through NWBO and to Cognate. That investigation should target Linda Powers.
There's never been anything positive to write about NWBO. I know that's a declaration you'll disagree with, but I believe it to be true. My job is not to be unbiased. My job requires me to look at the available facts/information and formulate an opinion. You and I might look at the same set of facts and reach a different conclusion.
If the facts change, my opinion would change. That goes for NWBO or any other company I write about.
Sure, comparing DCVax Direct to grapefruit juice is a tad hyperbolic, but not much. Removing DCs from a patient to "mature" them and re-injecting the same DCs back into the patient isn't going to have any significant effect on the tumor. These DCs were already unable to see the tumor cells. NWBO is not doing anything with Direct to change that.
It's an absurd project, which is why NWBO has never presented the full trial results formally. Instead, the company dribbles out misleading information presented in a way to make it look like Direct is having an effect. Of course, it's not.
If your job involves analyzing present-day events/data to make predictions about the future (as mine does), then being wrong is inevitable. It's impossible to be right 100% of the time. The best you can do is try to minimize your mistakes. And when you get something wrong, which will happen, you acknowledge the mistake, you learn from it and you try not to repeat the same error.
I'm not nonchalant about making bad calls on CLDX and CPXX but i'm not going to kill myself over the mistakes, either.
What you'll eventually come to realize is that my work on NWBO was not an attempt to bash the company or drive down the price of the stock. What I was doing was providing you a B.S.-free analysis and interpretation of events as they played out. My work was a warning that the company was not telling you the whole truth. I was trying to help you, and I will continue to do that.
Actually, I euthanized my dog. He had cancer and was suffering. It was a heart-wrenching decision but the humane thing to do.
I'm not the best-looking guy out there, but I don't think I'm homely. I certainly don't spend a lot of time getting angry over my looks. Thankfully, my wife is much more attractive and more of her genes passed on to my kids.
I do spend a lot more time trying to be right when it comes to my biotech stock opinions. I don't like getting things wrong, but it happens. I got CLDX wrong, as many of you like to remind me. I guess I got CPXX wrong, although my prediction was based less on the science than it was on Feuerstein-Ratain Rule. CPXX was the first micro-cap biotech company to violate the Feuerstein-Ratain Rule, which didn't anger me at all. I'm actually happy it happened.
I've been very right about NWBO for a long time. Some of you are just realizing it now, others on this board are still gnoring the truth. That's okay. It's hard to admit when you're wrong. I know from experience. But it's important to admit mistakes and learn from them. Eventually, you'll get there.