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My Dialogue With Adam Feuerstein On Northwest Biotherapeutics

|Includes: Northwest Biotherapeutics, Inc. (NWBO)

Perspective

I think that all investors in Northwest Biotherapeutics (OTCQB:NWBO) would concur that Adam Feuerstein has a vendetta against NWBO and its management. He has written 19 negative blogs (or is it 20) on the company just since March 2014. Since September of 2013, NASDAQ reports that the short interest on Northwest has increased from 635.000 shares to 8,000,000. Some observers have estimated that naked shorts could account for an additional 4,000,000 shares. Most investors believe that F-stein's blogs have played an important role in this aggressive short attack on this tiny company.

Feuerstein's communication platform is his blog on TheStreet.com and his tweets. He only infrequently responds to comments on his blog. In the 140 or fewer characters that he communicates with on Twitter; he can only state conclusions and not the underlying rationale for those conclusions. Feuerstein's style is to state conclusions with scant reasoning and he uses a vicious attacking style. Here is how he describes himself on Twitter "Sr. Columnist at TheStreet, aka the Col. Jessep of biotech/drug stocks. Data Are. I curse. Said one analyst: The likes of Adam Feuerstein attack viciously."

I think that most investors would like to see Feuerstein in a dialogue in which he has to support his conclusions. This hoped for event just occurred. In a recent article on Seeking Alpha, SmithOnStocks had the opportunity to go head to head with Feuerstein in the comments section of that article. This gives the reader the opportunity to gauge the strength of F-stein's arguments against mine. F-stein brought a knife to a gunfight.

How the Dialogue Started

A third party wrote an article on Seeking Alpha in which he went from a sell to a hold. It was not an in-depth article and I took the opportunity to put in some clarifying comments. This started an extensive dialogue with Feuerstein in the comments section of that article which provides a fascinating insight into his thought process. Here is the initial comment that I made that triggered the exchange.

Smith On Stocks Comment

In March of this year, the Paul Ehrlich Institute or PEI which is the German equivalent of the FDA also granted early access to DCVax-L and a separate German agency responsible for reimbursement has indicated that it will reimburse DCVax-L. I believe the reimbursement price will be in line with chemotherapies and targeted therapies or roughly $50,000 to $100,000 for a course of treatment. I believe that this will result in DCVax-L revenues from Germany in 4Q, 2014.

Also remember that DCVax-L is approved under this early access program for all grades of gliomas and recurrent glioblastoma in Germany, not just newly diagnosed glioblastomas as in the phase 3 trial. I consider this German early access more imminent and more important than the PIM designation by MHRA although the PIM designation is also an extraordinary achievement. For a complete discussion of the UK and German Programs follow this link.

The Company has also reported very interesting data on interim results of its phase 1/2 trial of DCVax Direct that indicate that the immune response being seen is consistent with the hypothesized mechanism of action. Remember that this phase 1 trial in is inoperable tumors so that patients cannot be offered effective therapy and are destined for hospice. These are very aggressive terminal cancers. With this in mind, there have been two highly encouraging case reports on a sarcoma and tpancreatic cancer patient. Here is the link for a discussion of the pancreatic cancer patient.

The Company has performed extremely well in achieving important regulatory validation of DCVax-L from UK and German regulators and in early trial data on DCVax Direct. The fundamentals have not been the problem. A prominent blogger (NYSE:AF) has a vendetta for NWBO and he is a problem. He accused the company of withholding efficacy data from an interim analysis of the DCVax-L trial. In actuality, there has been no interim efficacy analysis. This caused considerable weakness as AF alleged that the Company was somehow misleading investors because the interim efficacy analysis revealed problems with the trial and that this meant the phase 3 trial was going to fail. Of course, all of this was widely misleading since no efficacy analysis had been performed.

This AF allegation led to an unprecedented statement by the obviously outraged Chairman of the Data Monitoring Committee; this is an independent committee of leading physicians and academics charged with monitoring safety and efficacy in the phase 3 trial that has no connection to Northwest. The Chairman sharply rebuked the blogger (AF). He said that there had been no interim analysis for efficacy of the phase 3 trial. He said that the DMC has not provided any access for the Company to any clinical trial data. He said "that it is surprising and troubling to see inaccurate claims being made by commentators (the prominent blogger AF) who seem to lack a fundamental understanding of clinical trial monitoring. I have been on DMCs for more than 60 clinical trials, and I have never experienced this type of attack." Even though this blogger (AF) was shown to be utterly wrong, he did not acknowledge his mistake but just shifted to other bearish arguments.

This same blogger (AF) also maintained that the release of interim data from the DCVax Direct trial was unethical and that M.D. Anderson was very upset with NWBO. This strawman argument was also destroyed when two M.D. Anderson doctors appeared on a National Geographic documentary that focused on interim results of the pancreatic cancer patient.

Without these highly misleading and factually inaccurate attacks on NWBO that were curiously accompanied by aggressive short selling, I don't think that the degree of stock weakness we have seen would have occurred. These were totally unwarranted reasons for the stock to decline. However, we are seeing widespread weakness in small emerging biotechnology stocks and NWBO is in a financial position that will require it to bring in more cash, probably by yearend. These are two legitimate reasons for the stock weakness.

Adam Feuerstein Comment

Aroused by my comment, F-stein came back with a comment that attacked me personally. He essentially reiterated prior charges made by Richard Pearson that accused me of securities fraud, stock manipulation and being paid to write on Northwest Biotherapeutics. Pearson's article was based on conjecture and innuendo with no objective facts. I have challenged him to provide objective evidence; he has remained silent. Pearson shorted NWBO and then published his article on Seeking Alpha recommending sell.

The F-stein comment was deleted by Seeking Alpha because they considered it abusive and not germane to the discussion. Feuerstein then launched into a series of challenges to sections of my comment which created the opportunity for a dialogue.

Dialogue on the Lack of an Interim Analysis of the Phase 3 Trial of DCVax-L

The most important allegation that Feuerstein has made against Northwest Biotherapeutics is that an interim analysis for efficacy was conducted in the phase 3 DCVax-L trial, that management of Northwest saw the data and hid the results from investors. He then states that they then resized the trial in a desperate effort to account for the lack of efficacy that they saw in the interim efficacy analysis.

Anyone who understands how clinical trials are conducted immediately recognizes the absurdity of this allegation. Companies sponsoring clinical trials are blinded to results until the trial has concluded. Any breaking of this blind would be seen by regulatory agencies as introducing bias into the study and would mean that the study could not be a pivotal study for regulatory approval.

Although many commentators have pointed out to Feuerstein that this is a ridiculous statement, he has reiterated it over and over. The "missing or flawed or hidden" interim efficacy analysis is the cornerstone of his bear case. F-stein once more reiterated his position in the comments section.

adamfeuerstein Comment

Larry -- is there a functioning brain cell in that heads of yours? An interim efficacy analysis was clearly designed into the study. NWBO issued two press releases which mentioned an interim efficacy analysis, and as Robert informs you, the study protocol also includes an interim efficacy analysis?

Where are the data? If NWBO decided not to conduct the interim analysis, why? When was this decision made? Clearly, it must have been after issuing two press releases about it, so what changed?

And if there was no interim efficacy analysis, why did NWBO radically resize the study? Do you think Linda woke up one morning and just decided to add patients and require a s--tload more PFS events to trigger the final analysis for kicks? Or, do you think NWBO had some information -- data from an "interim analysis" -- which told them to resize the trial?

adamfeuerstein Comment

You don't resize a study without a reason. And the DCVax study wasn't just resized, it was radically altered by increasing by 125% the number of PFS events required for the final analysis. If you believe these changes were made without an interim analysis, you know nothing about clinical trial design and conduct and should not be invested in biotech or drug stocks.

NWBO issued two press releases in which it stated clearly, definitively, that an interim efficacy analysis was underway. It's been almost a year, where are the data?

SmithOnStocks Comment

In response I quoted what the chairman of the Data Monitoring Committee for the phase 3 trial of DCVax-L publicly stated.

"As the Company has stated clearly and specifically in its public announcements, the DMC has not conducted any efficacy analyses and the DMC has not provided any access for the Company to any clinical trial data," commented Dr. Curt Furberg, Chairman of the DMC. "The DMC adheres to established clinical trial monitoring procedures and does not release any data while the trial is ongoing. This is an important issue, and it is surprising and troubling to see inaccurate claims being made by commentators who seem to lack a fundamental understanding of clinical trial monitoring. I have been on the DMCs for more than 60 clinical trials, and I have never experienced this type of attack."

The above quote from Dr. Furberg was from this NWBO press release.

Adam, Dr. Furberg doesn't think very highly of you and I think that based on your continued hammering on the point that the efficacy analysis has been done and in your words was buried, that you believe that the Chairman of the DMC is lying. Hmmmm

Summary On Interim Efficacy Analysis Not Being Performed

F-stein has not responded to my comment, but clearly there has been no interim efficacy analysis. He has been extremely irresponsible in using this allegation as a cornerstone of his bear argument that the phase 3 trial is doomed to failure. It says a lot about F-stein. Clearly, he does not understand how clinical trials are run. More importantly, it speaks to his lack of research integrity and his eagerness to put forth straw man arguments that are clearly wrong. He doesn't like to be bothered with facts that contradict his conclusions. And finally, when shown that he has made a mistake, he will not admit it and would not even consider correcting it.

The German Early Access Approval for DCVax-L

F-stein has either ignored or labeled as insignificant the German hospital exemption early access program. This German approval by the PEI (the German equivalent of the FDA) was one of the most stunning events in biotechnology this year. PEI essentially made the drug broadly available to brain tumor patients before the phase 3 results are in. This was an absolutely stunning validation of the DCVax-L technology and a major coup for tiny Northwest Biotechnology. The MHRA (the UK equivalent of the FDA) has just made a similar decision for early access that is also stunning. F-stein quickly launched a series of misleading blogs to try to turn these positives into non-events and amazingly, he was successful

Here is what he commented on the early access programs.

adamfeuerstein Comment

How many companies can you name which generate significant revenue from compassionate use of an unapproved drug? Let me help you: None. Zero. It doesn't happen. It won't happen. Doctors are not going to prescribe an unapproved drug. There is no compelling reason to use DCVax under compassionate use because no credible data exist demonstrating any benefit.

The only reason NWBO has pursued these meaningless compassionate use designations in Germany and the UK is to throw up a smokescreen to hide the fact that it cannot complete the phase III study.

adamfeuerstein Comment

Ha! Again, Smith's lack of functional brain cells is stunning. I'm sure Linda is scouring the earth for a brain tumor patient who can be duped into paying for DCVax. Maybe a rich Russian oligarch will fall for it. Then, NWBO can issue a press release when his check clears. That will be so exciting!

Sorry, Larry. Early access and compassionate use are the same, and they're both meaningless.

Keep trying!

SmithOnStocks Comment

Northwest Biotherapeutics has been granted a hospital exemption in Germany. This allows DCVax-L to be used to treat patients for five years who have any grade of glioma, not just glioblastoma multiforme. It also allows treatment of lower grade gliomas, both newly diagnosed and recurrent. This is a major validation of the promise of the technology.

The applicable law for the hospital exemption program went into effect in the summer of 2011. For 2 ½ years there have been numerous applications submitted. However the Paul Ehrlich Institute (the German equivalent of the FDA) has only approved three products. Two were products which were on the market prior to the passage of the hospital exemption and were grandfathered. These were non-systemic products used in regenerative medicine. DCVax-L is the first product to be approved that was not grandfathered. It is the first immune therapy approved by PEI, the first systemic therapy (the two German products were regenerative medicine products) the first cell therapy product, and the first product approved for a non-German company.

DCVax-L also received a separate and quite favorable approval from the central reimbursement authority in the German system. This is another validation of the technology. Under the hospital exemption, NWBO is not allowed to request reimbursement, only hospitals can apply. The investment significance and still another validation of the DCVax-L technology is that six major hospital centers applied for reimbursement of DCVax-L.

It is extraordinary for a product that is still in clinical trials to be approved for reimbursement. It is unheard of for a product to get reimbursement while still in clinical trials. The usual reimbursement path is to finish the clinical trial, gain regulatory approval, introduce the product and then seek reimbursement. This is a process that takes one to two years.

Before reimbursement is gained the hospital has to request and negotiate reimbursement on a patient by patient basis. With reimbursement, each patient treated is reimbursed at a set price negotiated with the payor. With the hospital requesting reimbursement, NWBO can now negotiate the price with the health care plans. This is all while the phase 3 trial is not completed. This process is tantamount to receiving full approval and full reimbursement as would be the case with a newly approved drug. The only difference is that NWBO cannot directly promote the drug, but with the high awareness of glioblastoma patients and physicians, not much promotion will be needed.

Some bloggers have stated that this is just compassionate use and on tweeted "compassionate use, who cares". This reflects lack of understanding of the German system. The first difference between the older compassionate use system (commonly referred to as named patients) is the number of patients that can be treated. With named patient compassionate use, only one patient can be treated at a time. The specific patient has to be named and the physician or hospital has to prepare a regulatory document comparable to an IND. Moreover, it is usually restricted to patients who are ineligible for approved drugs or drugs in clinical trials.

Then you have to seek regulatory approval for just that one patient and for each subsequent patient the process has to be repeated. In contrast, the hospital exemption allows the treatment of all patients with newly diagnosed and recurrent gliomas (not just newly diagnosed glioblastoma). Hospitals do not have to prepare paperwork for each individual patient. Moreover, the hospital exemption allows them to do this for five years. At the end of five years, they can apply for another five years.

The second difference is that under compassionate or named patient use, the payor, hospital or patient cannot be charged. Under some conditions, the drug sponsor can seek reimbursement for cost incurred. Very importantly, NWBO will be paid a price which is in line with that usually given for important new cancer drugs; they are usually priced at $50,000 to $100,000 per course of therapy. And of course, DCVax-L will receive reimbursement in the same way as a drug approved through the normal regulatory process.

Summary Comment On Early Access Programs

The denial of the importance of the German hospital exemption in validating the technology of DCVax-L and the potential for revenues from Germany as a result of this has been another key element of the Feuerstein bear case. I think his comments show total confusion on his part about what these programs are all about.

What Can We Conclude About Adam Feuerstein

It is interesting to see how other people who made comments on this article interpreted the dialogue between F-stein and SmithOnStocks.

diamondjim61

Wow! Quite the dialogue. This really shows how immature and illogical Adam Feuerstein is... I had only thought this previously, now I know... The difference is several educated well thought responses vs. the name calling of school child. you guess who is who.

rkmatters

AF formulated his opinion on dendritic cell technology on day one. He's been dead set against the merits of the science and that's why he continues to write one sensational blog after another. He unfortunately let his dislike for Linda form a cataract over his eyes. He can't see straight, and as such, he lost his judgment ability to be both rational and objective. He sees himself as a Sherlock Holmes hero and instead he's a foolish man on a vengeful mission. Clearly if the DMC, the MHRA, and the PEI can't get him to change his warped view, nothing will.

flipper4

Adam, The Chairman of the DMC called you out. Now you are also calling him a liar? Do you have proof a DMC analysis was conducted? No. Do you have proof they are hiding a DMC analysis? No. Do you have proof NWBO cannot complete their phase III trial? No.

By implication you would be calling the FDA and International Regulators liars as well. Do you have proof of this? No.

You are making very serious allegations and doubling down. Let me know how that works out for you.

slapa

AF: your comments are comical, and very stupid. You are either very smart to create constant controversy, which will generate internet traffic to s.....com, or you are very very stupid. I think you might have some "issues" and you probably should seek professional help...

jgons2014

The purpose of AF article is probably to add another straw to push the price a little further south, in order to let the shorts cover. This could be the last chance, or one of the last chances, for the shorts to retreat without much damage. Starting from the end of the year to 2016, NWBO has many important events: German pricing, UK FDA final decision, treatment income from German and UK, Direct I results, Direct II ongoing, L enrollment completion, L two interim studies, L final results, etc. With the arrival of these events, not just long-term holders like us watch the stock, many short-term bio-traders will also swamp in. At that time, it will gets more and more difficult for the shorts to cover, unless the clinical trials are bust.

karlef

"The only reason NWBO has pursued these meaningless compassionate use designations in Germany and the UK is to throw up a smokescreen to hide the fact that it cannot complete the phase III study."
and Germany and the UK equivalents of our FDA went along with it???

"How many companies can you name which" have gotten such approval from Germany and/or the UK?
none, zero, zilch -- ONLY Northwest has ever received such designation or approval which is NOT compassionate use. i repeat, NOT compassionate use. Northwest will absolutely be receiving a negotiated payment which will include a profit margin.

"no credible data exist demonstrating any benefit."
so the PEI in Germany is just winging it, and exposing patients to pure shot-in-the-dark medicine? and the UK erred in granting Northwest PIM designation which specifically REQUIRED them to make such a finding???

adam, why do you keep working so hard to find such off the wall paranoid conspiracies and alternative explanations instead of simply trusting what the DMC and Germany and the UK are saying?

jgons2014

Resizing is also designed into the study. It's understandable to stop the early-projected interim analysis after a decision of resizing. The two interim analyses are still there after resizing.

AF, you are intentionally to turn the cause and effect upside down, in order to reach your shorting target. If not because of knowing your stand, I would suggest you to see a doctor and check whether you have brain tumor or not, which could be the cause of your irrational thinking and persistent bash. Unbelievable 20 bashing articles from you to such a tiny biotech company!

karlef

had to copy your post this time so i would have a record of it before it was deleted, but want to make a few points about process that you still seem confused about even after the clarifications from the DMC.

-- designing an efficacy analysis into a study does NOT make it mandatory, and the decision is entirely up to the DMC. i repeat, entirely.
-- Northwest issued press releases based on expectations that an interim analysis would be or was being done. the fact that they did this is evidence that Northwest was NOT in communication concerning an interim analysis.
-- however, Northwest was in contact with the DMC concerning the trial expansion which had been proposed months before in an effort to make the trials more inclusive, meaningful, and definitive. that had absolutely nothing to do with data from a stillborn interim analysis because Northwest, as just explained, had no knowledge of the data.

Adam, it is way past time for you to look deep inside and ask whether you want to keep doing this or if instead you might want to redeem your soul and start speaking the truth about Northwest rather than posting more of your creative distortions and denial of the facts.

Final Comments On How People Feel About F-stein

In an effort at fairness, I would like to include comments that support F-stein. Not surprisingly, there weren't any.

Disclosure: The author is long NWBO.