Seeking Alpha

Northwest Bio says AF off target

  • Northwest Biotherapeutics (NWBO) asserts that Mr. Feuerstein's June 19 article is misleading and inaccurate. For starters, it says that has not received a "rebuke" from any clinical trial site nor is there a basis to receive one. It claims that it has consistently stated that it would release interim data on an ongoing basis regarding the DCVax-Direct Phase 1/2 clinical trial. It confirms that the disclosed data originated from medical files sent to the company from the trial sites and a CRO, but it claims that reporting interim results is not unusual for an unblinded open-label study like DCVax.
  • CEO Linda Powers says, "...Feuerstein seeks ever more sensationalized ways to try to smear the Company. This is not even the semblance of professional analysis. We condemn this attack campaign and appreciate the strong support we are receiving from shareholders, patients and other commentators. We intend to continue our progress undeterred."
From other sites
Comments (18)
  • deercreekvols
    , contributor
    Comments (5587) | Send Message
     
    At what point does the SEC or DOJ take action against Adam Feuerstein and his employer?

     

    How many more companies will they ruin with false accusations?
    20 Jun, 09:20 AM Reply Like
  • longimgn
    , contributor
    Comments (295) | Send Message
     
    It will only be proven to be false years from now after all the tests and time goes by that demonstrated beyond reasonable doubt that this treatment is the cause for cancer remission or at least, stabilization....Time is on AF's side...Only results will decide and dictate the truth....For the sake of the hopeless patients on this trial and many others like it, I hope what they are getting is helping them win the battle against a terrible, progressive and life-threatening disease...
    20 Jun, 09:42 AM Reply Like
  • jgons2014
    , contributor
    Comments (95) | Send Message
     
    Dr Buzdar himself has released Bristol-Myers Phase I ongoing efficacy data for chemotherapy. What interesting is that Dr Buzdar prohibits NWBO from doing so for immunotherapy! Why?

     

    http://bit.ly/1kU3afF

     

    It IS ASTONISHING THAT Dr BUZDAR AT MD ANDERSON WOULD TALK LIKE THIS. If not for his own agenda, I seriously doubt Dr Buzdar's capability as clinical investigator in MD Anderson.

     

    That this was done in cooperation with AF shows the scale, planning and true nature of this attack. There is not a single sentence that states NWBO's results are falsified. Only that early success could be misconstrued. Is that news to anyone here? Is anything that LP said in her statements untrue? Hell, no!
    20 Jun, 10:12 AM Reply Like
  • theredbaron8888
    , contributor
    Comments (27) | Send Message
     
    Very pertinent information, jgons2014. There is a serious case of professional ethics - and a conflict of interest (look up Dr. Buzdar's past links with Big Pharma) involved here that MD Anderson has so far failed to address so far.
    20 Jun, 10:25 AM Reply Like
  • P Man
    , contributor
    Comments (1199) | Send Message
     
    The issue here is that NWBO is releasing positive information for a trial that is still enrolling patients, and in that, it could be perceived as coercing new patients into a trial where it is not known that the drug works. In the abstract linked by jgons, enrollment had already completed. Thus, there is no "promise of benefit" to potential patients for that study or cohort.

     

    It is okay to provide data updates for studies where enrollment is closed, but it is not appropriate to do it for studies still enrolling patients. That is what the issue is.

     

    The issues here aren't so much with the SEC but with the FDA.
    20 Jun, 01:23 PM Reply Like
  • theredbaron8888
    , contributor
    Comments (27) | Send Message
     
    The screening/enrollment of all 36 patients for the trial is already done. This had happened prior to ASCO.
    20 Jun, 01:37 PM Reply Like
  • P Man
    , contributor
    Comments (1199) | Send Message
     
    That may be the case, but it's hard to tell that from the press release they issued. They talk specifically about 20 of the patients and then allude to seeing how things play out with all of the patients. One could take that to mean they hadn't been enrolled yet.

     

    It is odd, though, to issue an efficacy update when not one of the patients has even completed the treatment regimen.
    20 Jun, 02:31 PM Reply Like
  • tinsley09
    , contributor
    Comments (277) | Send Message
     
    P man,No academic research faculty member (if he hopes to prevail before a faculty senate of his peers)will open his mouth and comment on clinical research data NOT his OWN,and which HE HAS NOT examined HIMSELF,regardless of how preliminary and UNCONFIRMED the data is.The data is Vivek Subbiah M.D et al's and he has cautiously chosen not comment PUBLICLY till the study is completed.I respect his conservative posture.Aman has chosen to pontificate on data he has not seen and to unburden his verbiage to a third rate Wall Street reporter ,of questionable integrity.
    The issue of the completion of clinical enrollment status is tangential to the VERY IMPORTANT issue of the1) reliability and 2) potency of the experimental EFFECT even in a small case study data set, without placebo controls.
    It appears that Aman Buzdar MBBS(an EXCLUSIVELY clinical degree) can be most charitably described as a good technically trained clinician, who was easily manipulated by A.F. of the Street. Aman Buzdar appears to lacks a lively sense of his own research academic limitations and responsibilities.
    22 Jun, 03:07 PM Reply Like
  • Grizzle
    , contributor
    Comments (66) | Send Message
     
    Adam F. is a paid liar pure and simple and has been wrong about so many stocks at this point it is amazing anyone reads his articles. I suppose he just gets attention because their so controversial. And Dr. Buzdar is a dispicable human being. Just look and read his ratings on Vitals.com. The man is involved with chemotherapy clinical trials where HE HIMSELF puts out early phase 1 data before the trial is complete!! Hypocrite??! Also he works in clinical trials for astrazeneca and Bristol myers which will suffer theirs when DCVax gets approved.
    20 Jun, 10:26 AM Reply Like
  • Grizzle
    , contributor
    Comments (66) | Send Message
     
    And incase anyone doesn't know already. Dr. Buzdar works on clinical trials for cancer giants Bristol Myers Squibb and AstraZeneca. He develops new poisons, I mean chemotherapy agents. If you get cancer, please for the love of God don't go through Chemotherapy! It is pure poison and destroys your whole immune system. Go to Germany or find another therapy.
    20 Jun, 10:29 AM Reply Like
  • Rospim
    , contributor
    Comments (13) | Send Message
     
    why Mr. AF wants to destroy NWBO?.Please MR AF let Linda Power keep working for such a great cause believe the immune system is the way to go to defeat not only cancer,but any disease AF Remember,lies for personal gains is self defeat.
    20 Jun, 11:43 AM Reply Like
  • theredbaron8888
    , contributor
    Comments (27) | Send Message
     
    A further instance of unprofessional behaviour by Dr. Buzdar is highlighted in Olive78's post on Investor Hub,

     

    "This comment was made purely to sow the seeds of doubt that NWBOs technology could actually be working. It is HIGHLY irregular for an investigator at a clinical trial site to publically negatively comment on the scientific and technical merits of a ongoing trial at their home institution, and this was no accident. "

     

    Olive78 further adds,

     

    On June 2 Celldex, which is AFs sweetheart, released preliminary data for its phase 1 trial of the Varlilumab for the treatment of lymphoid and solid tumor malignancies (http://yhoo.it/1pQhYnf). Keep in mind this trial is still recruiting, and they gave specific information (or case studies if you will) about individuals, and the "promising signs of clinical activity" of their drug. Sound familiar...

     

    Here is a fun snippet which would probably shock and dismay Dr. Buzdar

     

    "In the lymphoid malignancies dose escalation arm (n=24) two patients are currently continuing treatment and have not yet been evaluated for response. As previously reported, a heavily pre-treated patient with aggressive Hodgkin lymphoma achieved a complete response (CR) after three cycles of varlilumab (0.3 mg/kg). She currently remains in remission at 12.9+ months. Six additional patients with Hodgkin lymphoma have been enrolled, the majority to the 10 mg/kg dose level, with one patient awaiting initial response evaluation. Three additional patients with non-Hodgkin lymphoma have experienced stable disease (SD) with a progression-free survival (PFS) range of 4.5 to 14 months. One of these patients experienced significant tumor shrinkage (36%)."
    20 Jun, 11:49 AM Reply Like
  • P Man
    , contributor
    Comments (1199) | Send Message
     
    12 and 14 month data is a lot different than 2 and 8 week data, though, wouldn't you agree?
    20 Jun, 10:41 PM Reply Like
  • jgons2014
    , contributor
    Comments (95) | Send Message
     
    P Man, as yourself working in the fields over 20 years, don't you know the effective data collection points totally depend on the properties of agents (drugs or therapies)?! Some toxic poison can get people dead in seconds. You want to wait for 2 years to confirm the person is dead?
    20 Jun, 11:17 PM Reply Like
  • P Man
    , contributor
    Comments (1199) | Send Message
     
    Of course not. Reporting safety data is always important. And I suppose to be able to say that nobody died from your drug in 8 weeks is important too, I guess.

     

    But Dr. Rice, please read aloud the title of the press release noted here:

     

    http://yhoo.it/1p1tsVy
    20 Jun, 11:56 PM Reply Like
  • skiwithme
    , contributor
    Comments (5) | Send Message
     
    @P Man, I have read the article aloud and these are some points I picked out as important when considering NWBO and DCVax-Direct -

     

    "...in the ongoing Phase I/II clinical trial..."

     

    "...plans to report more details when the patients are further along in the treatment regimen..."

     

    "...patients have received 4 of the 6 planned injections..."

     

    "...The 4th injection is administered in week 8 of the 32-week treatment regimen..."

     

    "...These early glimpses are..."

     

    "The 4th injection is still quite early, as it is just 8 weeks into the 32-week treatment regimen."

     

    "Patience will be important as we move through the rest of the treatment regimen..."

     

    "The data may get either better or worse as more data is collected."

     

    "This growing body of initial early data..."

     

    All of these statements tell me this is early on in this clinical trial and the data is NOT final data from a completed clinical trial. This tells me to take all of this data and be hopeful, but also very cautious because they are not even a 1/4 of the way into the trial.

     

    If NWBO was not reporting any of this data from an open, unblinded trial you and others would be asking what NWBO is hiding by not releasing any data from this trial.
    24 Jun, 09:13 PM Reply Like
  • P Man
    , contributor
    Comments (1199) | Send Message
     
    I wouldn't be asking as I know there would be no expectation of reporting efficacy data this early in a clinical trial.
    25 Jun, 04:28 PM Reply Like
  • Joe McCann
    , contributor
    Comments (113) | Send Message
     
    New to looking at NWBO - I honestly am curious what a clinical trial design expert thinks of things or a statistician. Adam can be wrong, and certainly has been right before, so to me it warrants a look.

     

    At 360mm market cap a clean review from an expert in my opinion would make this an incredibly interesting 3-10x return story over the next 12-18 months.

     

    I know many people on this board are very passionate about the stock and trial. I appreciate that and am stating that my only hope from this project is to get more unbiased information.

     

    If you're interested please join me, submit your questions, and let's see what we learn.

     

    http://bit.ly/1oAHvR3
    15 Aug, 12:17 PM Reply Like
DJIA (DIA) S&P 500 (SPY)
ETF Tools
Find the right ETFs for your portfolio:
Seeking Alpha's new ETF Hub
ETF Investment Guide:
Table of Contents | One Page Summary
Read about different ETF Asset Classes:
ETF Selector