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Thanks, Mav. I particularly like this quote from your ref link:
"In addition, private placements must comply with state laws and anti-fraud provisions of securities laws. Companies must disclose to potential investors all of the pertinent information needed to make a fully informed decision."
Same old Pyrhh. Everyone just put him ignore and he will go away. He adds nothing but FUD to the conversations here.
all this incessant whining finally got you a nice big ignore.
FWIW from a poster on YMB/NWBO:
I am an attorney, and I know Les and Linda fairly well. I have spoken to them at length. I am very confident that they are extremely diligent and honest. Les would never ever risk his reputation in getting into a scam or misrepresenting. He was a partner at a top law firm for over thirty years and is still very well connected. The late Jim Schlesinger(former Secretary of Defense) was a close friend of his. Les is an extremely careful attorney and knows what he is doing. Believe me he is aware and he does sometimes read these chat boards. I have suggested he do so as these boards are a microcosm of at least investor sentiment. While not proof of anything, and of course he may be biased( I do think he is open to reason and facts and understands well articulated opinions), most of what he sees on the boards are pure conjecture and half baked opinions which you can choose to believe....or not. Spoken like a true lawyer but the import is....like a:;r:;s:;e:;h:;o:;l:;e:;s, everyone also has an opinion.
I trust Les and Linda and the team of scientists and collaborators they have assembled. I'd rather believe NWBO management( if you don't you should not invest), Woodford, the UCLA researchers, et al and people like yourself, Reefred, Flipper( who I think is just amazing) who have a scientific background and are credible. Kitchen contractors? Self educated? My opinion is that half baked knowledge is a dangerous thing. I made the extremely stupid mistake of giving into fear and FUD spread by similar so called MB experts in AVNR and sold too early. It was over a 5 bagger from my levels on acquisition. Never again. I am confident in NWBO:)
Thanks TC for a sane, rational explanation.
Give me a break. RK writes a tome-length post questioning Direct (in response, she claims, to a question raised by iclight--iclight? iclight? who bothers responding to the same, months-long, complaining litany from him?). With the exception of the quote re 8 patients whose disease progressed, most of RK's fears are based upon SEC boilerplate, where NWBO like all firms lays out every conceivable risk imaginable. And now, out of the blue, gloating, insensitive Pyrr returns, breaking his self-imposed exile from this board. Just a coincidence? I don't think so. Anyway, nothing has changed re NWBO. We are in a PR desert until the Sept conference.
The bio index is down almost 5% today. Did RK's long note bring that down too?
There goes the neighborhood.
Thank you Sentiment! Beautiful, cogent reply to Pyrr that blows away all his arguments. A bases-loaded home run.
Post from YMB:
abeta4238 • 1 hour 4 minutes ago
5 users liked this posts users disliked this posts 1
Reply
NEW YORK, Dec. 15, 2014 Angel Wong, Analyst for GBI Research, says DCVax-L will demand a premium price once it hits the market
NEW YORK, Dec. 15, 2014
Angel Wong, Analyst for GBI Research, says
As DCVax-L has been shown to extend OS substantially,
the vaccine
*****will demand a premium price once it hits the market.*****
The Glioblastoma Multiforme (GBM) treatment market
is forecast to grow rapidly from
$301 million in 2013
to $623 million by 2020,
at a Compound Annual Growth Rate (CAGR) of 10.9%.
less efficacious treatments Cotara and Rindopepimut (CDX-110),
which will enter the global GBM treatment market in 2016 and 2017,
respectively.
DCVax-L has the added advantage of facing few other
active competitors in the current high-risk GBM therapeutics market.
Amen. Perfect summary.
Woodford is to NWBO as Buffet is to Company N. A positive sign and a vote of confidence.
Incredible work. Thanks so much for your time and effort.
Not sure how your account works, but with E-Trade if someone gained access to the account it would still take them several days before they could withdraw money into their own bank account. They would first have to add a new bank account and then have that bank account verified, which usually takes 3-5 days. If your account has similar safeguards, you would have a few days to rectify the situation and prevent the fraud.
Anyone in D.C. area know if the Pearlstein article made it into the print edition of the Washington Post newspaper today?
Larry Smith has a new article on NWBO and the UK announcement. http://smithonstocks.com/northwest-biotherapeutics-exciting-news-on-potential-for-early-patient-access-for-dcvax-l-in-the-uk/
Larry Smith (Smith on Stocks) has a new blog piece on Adam Feurerstein: "The Heat Is On".
http://smithonstocks.com/adam-feuerstein-the-heat-is-on/
On the NWBIO website, under Investors & Media tab, is MBS Value Partners (mbsvalue.com) a new item, i.e., is this a new PR team working with NWBO. I don't recall seeing it before.
At about 21:00 he actually mentions the 10 year study by NWBO
Several very near catalysts might help the share price. I posted previously (and I think it bears repeating) that I think we will have 3 PRs between the 24th of July and the 15th of August just on D alone. You can view the 36 Ph I patients mentioned in the 6/11 PR as comprised of 3 cohorts. The lst cohort is comprised of the 9 patients who had their 4th injection (at 8 weeks). They will have their 5th injection(16th week) by the end of July or early August., so we might get an update on them around mid August (2 months from the 6/11 PR). The second cohort consists of the 11 patients who had completed their 3rd injection (at two weeks) when the 6/11 PR came out; they will be receiving their 4th treatment (at 8 weeks); and their results might be announced around the 24th of July, approximately 6 weeks after the 6/11 PR. (Note: 4 of this group were already reporting very positive results identical to what was conveyed regarding the 9 patients who had had 4 treatments). The third cohort consists of the 16 patients who were just entering Ph I about the time the first cohort had their 4th injection. This last group should have finished their 3rd injection (at 2 weeks) by now and some might be close to getting their 4th injection (assuming they are staggered). Once the number finishing that 4th injection is large enough, say 8-10 or more, then a PR on their results can be expected. This could be shortly after the upcoming results on the 2nd cohort are released, so say around the lst of August.
And of course, at any time there could be news re: UK or EU approval, Germany pricing, FDA approval, etc.
Larry Smith has a more detailed rebuttal to the Pearson article on his blog, if you are interested:
A new blog titled "Northwest Biotherapeutics (NWBO, Buy $6.75): Responding to Serious Unsubstantiated Allegations by Richard Pearson" has been posted on SmithOnStocks.com. You can view this article at http://smithonstocks.com/northwest-biotherapeutics-nwbo-buy-6-75-responding-to-serious-unsubstantiated-allegations-by-richard-pearson/.
One of many reasons the shorts might be getting desperate of late is that we might have 3 PRs between the 24th of July and the 15th of August just on D alone. You can view the 36 Ph I patients mentioned in the 6/11 PR as comprised of 3 cohorts.
The lst cohort is comprised of the 9 patients who had their 4th injection (at 8 weeks). They will have their 5th injection(16th week) by the end of July or early August., so we might get an update on them around mid August (2 months from the 6/11 PR).
The second cohort consists of the 11 patients who had completed their 3rd injection (at two weeks) when the 6/11 PR came out; they will be receiving their 4th treatment (at 8 weeks); and their results might be announced around the 24th of July, approximately 6 weeks after the 6/11 PR. (Note: 4 of this group were already reporting very positive results identical to what was conveyed regarding the 9 patients who had had 4 treatments).
The third cohort consists of the 16 patients who were just entering Ph I about the time the first cohort had their 4th injection. This last group should have finished their 3rd injection (at 2 weeks) by now and some might be close to getting their 4th injection (assuming they are staggered). Once the number finishing that 4th injection is large enough, say 8-10 or more, then a PR on their results can be expected. This could be shortly after the upcoming results on the 2nd cohort are released, so say around the lst of August.
Great post, Sentiment. I thought too that the math was fuzzy, but you nailed it perfectly.
Barron's has an article on the dust-up today. You can find it on Yahoo under Company News once you pull up NWBO. Here are some quotes from LP: <But Northwest Bio CEO Linda Powers denied all the charges contained in the Seeking Alpha Piece. "Each of the major points about us are not accurate," she told Barrons.com Monday. "Pearson writes that the stock price has gone up because of promotion articles. Nowhere does he mention the real reason, that the company has made tremendous operational progress.">
And then another paraphrase "Powers, Northwest Bio's CEO, confirmed that her company has a longstanding business relationship with MDM Worldwide. But she argues that the firm only helps her company with its Website and by promoting Northwest Bio on social media sites such as LinkedIn and doesn't commission freelance writers to do favorable articles, as Pearson alleges. Powers said that after reading Pearson's article, she reached out to MDM just to make sure that the company hadn't engaged writers to do promotion pieces on the biotech's behalf. She said that MDM confirmed that it hadn't.
She also added that principals with MDM have told her that the firm has never engaged Redfish to do any work for Northwest."
Yes, and it also probably puts to rest the recent conspiracy theories re Big Pharm and the AF crew.
NWBO not marginable at e-trade either.
Fraunhofer fully supports NWBO press releases regarding German approval. This was just posted on YMB:
Read this press release from the Fraunhofer homepage and you will see that AF is a cheat.
He always states that Northwest Bio makes believe a German "hospital exemption" for DC-Vax is anything more than compassionate use.This is a lie.
Northwest Biotherapeutics receives authorisation for new cancer therapy in accordance with §4b German Medical Act
Press release11.03.2014
Since 2011 the Fraunhofer Institute for Cell Therapy and Immunology (IZI) has supported the North American company Northwest Biotherapeutics (NWBT) in the clinical trials on an innovative, autologous method within cell therapy intended to treat brain tumours (glioblastoma multiforme).
In Europe also, the so-called DCVax-L method has been evaluated since June 2013 as part of a phase III clinical study; this multi-centric study was initially launched in the United States. Cooperating closely with Fraunhofer IZI and Pharmalex GmbH, the company reached a further milestone in the clinical application of DCVax-L on 6 March 2014. Based on a two-year, extremely intense regulatory process the Paul-Ehrlich- Institute (PEI) granted NWBT the authorisation to apply the method to patients outside of the ongoing clinical study within the framework of the regulations defined under §4b German Medical Act (»hospital exemption according to the Directive (EU) no. 1394/2007«). NWBT and Fraunhofer IZI are hence the first institutions to successfully apply for this form of authorisation for a new product from the class of somatic cell therapy agents. The specific agents for the patients in the clinical study and for provision under authorisation according to §4b German Medical Act will be manufactured at Fraunhofer IZI.
Further information and contact details for physicians and patients can be found in the detailed press release by Northwest Biotherapeutics:
http://nwbio.com/nw-bio-announces-two-german-approvals-hospital-exemption-forearly-access-program-with-dcvax-l-and-eligibility-of-dcvax-l-for-reimbursem
On the contrary, I think the truth will win out and as more successful trial data emerges the company will report it. In about 3 weeks, the rest of the 11 patients in the 20 patient cohort (of which 9 were recently reported on) will reach their 8 week (4th injection) mark. If their results are similar to the initial 9, NWBO will of course report it, with the same caveats about future results being better or worse. And not long after that, the initial 9 will be receiving their 5th treatment. At some point, in the face of continued good results AF's attacks will lose their sting and perhaps (and rightfully) be ignored altogether.
FWIW: Open-label trial
From Wikipedia, the free encyclopedia
An open-label trial or open trial is a type of clinical trial in which both the researchers and participants know which treatment is being administered.[1][2] This contrasts with single blind and double blind experimental designs, where participants are not aware of what treatment they are receiving (researchers are also unaware in a double blind trial).
Open-label trials may be appropriate for comparing two very similar treatments to determine which is most effective. An open-label trial may be unavoidable under some circumstances, such as comparing the effectiveness of a medication to intensive physical therapy sessions.
An open-label trial may still be randomized. Open-label trials may also be uncontrolled, with all participants receiving the same treatment.
Great stuff, Highwayman, you nailed it perfectly. Thank you.
I would really like to see NWBO respond to AF's recent attack, and in the middle of the rebuttal have a quote from Linda saying something to the effect that, "It is a shame that a small bio-tech company like ours, in the vanguard of development of personalized cancer vaccines designed to treat a broad range of solid tumor cancers, has to waste precious time addressing false charges by the likes of AF and his band of short-sellers."
Posted on Yahoo by HoppingMad:
Rebuke of Dr. Buzdar
First of all this guy got his medical degree from a third world country in 1967. I personally wouldn't want this "Dr" anywhere close to me if I needed medical attention.
Secondly, he is not a stranger to controversy. In an article in "The Journal of Clinical Oncology" Aug 2004, "Dr" Buzdar is strongly rebuked for poor reasoning skills by Henning Mouridsen and Hilary A. Chaudri-Ross.
Thirdly he has massive conflicts of interests. This from a disclosure at the bottom of an article in Clinical Oncology dtd 2009 Vol 6 no 6. "Aman Buzdar is on the Speakers bureau and receives grant/research support from Astrazeneca and Genentech. He also receives grant/research support from Taiho, Lilly, Roche and Pfizer, and is on the Speakers Bureau for Amgen.
fourth problem. See Houson Chronicle News Sep 16 2012. "M.D. President seeks waivers to conflict of interest policy"
This M.D. Anderson place may not be as "prestigious" as it's made out to be, and Linda Powers may simply be protecting the shareholders interests by being forthcoming with these preliminary releases. Sort of like a witness to a crime releases information so the "mob" doesn't kill her.
Fossilman on Yahoo posted this:
A patient who just got back from Germany....
I donated to a mother fighting GBM months ago and here is the update. Germany treatments are real!
We are in Frankfurt, (lovely city) Germany right now and our flight home is in 4 hours! We've been here for two weeks and Kristen received her dendritic cell vaccine as well as some other immunotherapy treatments. Everything has gone extremely smooth and we were thrilled with the doctor and the whole process. We met several other Americans who were undergoing the same treatments here (one being an ER doctor from Boston) and are hearing positive success stories all over. This treatment is meant to activate the body's own immune system to bring down the cancer. We are now at a watch and wait period. It usually takes a few months/booster shots to start working if it's going to. The goal would be for tumor shrinkage, but it may just be the tumor remains stable and doesn't grow- which is fine too. Prayers, thoughts and energy are now going towards Kristen's body responding the the new dendritic cells and them activating her T-cells in order to fight the cancer.
Kristen will be flying quite often to NYC to receive her booster shots. In the beginning it's once a month, then will spread out every few months. If it seems to be working, she will probably need to continue for many years. The German doctor (or his son, also an oncologist doctor) flies to NYC every month and brings her and a group of other American patients their shot. The cost for this is not outrageous considering cancer treatment, but will be about $5,000 each time. We are continuing to raise funds to help her cover the treatment.
Thank you all from the bottom of my heart for making this possible. Kristen is missing her little girls at home like crazy (i miss my nieces too!!!) We are happy to have visited Germany, but can't wait to get home to our family.
Many here probably don't realize there is an IGNORE button on iHub. Click on the user's name in the little box on the left next to his or her message. Scroll down a few lines, and click on IGNORE. That's it. In the event you change your mind later, you can always un-IGNORE them.
"Today's PR came out of the blue." Actually, we can expect many more PRs on the Direct trial. According to the PR 20 patients have received 3 injections, 9 of which (featured today) have received their 4th injection, i.e., they are in week #8. Over the next 6 weeks, the 11 who have already had their 3rd injection (their week #2) will be moving into their week #8 for their 4th injection. We surely can expect a PR on their results. By then, the 9 featured in today's PR will be only a few weeks shy of receiving their 5th injection (week #16 for them), and another PR should ensue. All the while, the remaining 16, who as of today either are waiting to begin their injections or have already started, will be reaching their 2nd week, and then their 8th week treatments; not all at once of course but all benchmarks for issuing more PRs. If the outstanding results reported to date continue for these future benchmarks, we should see strong PPS follow-through. Maybe this was what Les meant when he spoke of a ramp up.
You can also write directly to Dr. Siegel via his website: http://www.doctorsiegel.com/
Good idea re: Facebook. Just post this link to your homepage to let people know: https://finance.yahoo.com/news/dcvax-direct-trial-indicates-further-121500060.html Nice big headline to get people's attention.
Pyrr, your Seeking Alpha article is a tour de force, and your long comment therein is masterful. Thank you so much for all your time and effort. You are sincerely a rare and gifted individual and it is a delight to know you, if only through these message boards. Thanks again.
That the bio-index itself is down, and the overall market is lackluster, doesn't help much.