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No problem! I can certainly condense into key points without all the hoopla.
Schedule got seriously thrown off today so I am a little late getting this out for input. Tore my meniscus this weekend and got scheduled for surgery today Anyway, I threw this together quicker than I wanted but here is what I have so far (I purposely left out any of the negative news that has occurred as of late)
Dr. Siegel,
I wanted to bring to your attention a clinical trial cancer therapy that you showcased on Fox News back in November 2013 titled, “Could our own bodies hold the key to curing cancer.” The company I am referring to is Northwest Biotherapeutics and their cancer vaccine is DCVax. The highlight of this piece was showcasing DcVax L. This Phase III trial is designed to evaluate the impact on disease progression and survival time, as well as safety, in patients following treatment with DCVax(R)-L, an immunotherapy treatment for GBM. The experimental therapy uses a patient's own tumor lysate and white blood cells from which precursors of the dendritic cells are isolated. The dendritic cell is the starter engine of the immune system. The white cells are then made into dendritic cells and they are educated to "teach" the immune system how to recognize brain cancer cells.
Since the episode on NWBO/DCVax aired on Fox News, the Company has continued to make significant progress. In March of 2014, NW Bio announced that the German reimbursement authority (Institut Fur Das Entgeltsystem Im Krankenhaus, or InEK) has determined that DCVax-L treatments for glioma brain cancers are eligible to obtain reimbursement from the Sickness Funds (health insurers) of the German healthcare system. Applications for such reimbursement eligibility may only be submitted to InEK by German hospitals, not by a company. Six major hospital centers across Germany applied for such reimbursement eligibility for DCVax-L for glioma brain cancers. The amount and terms for such reimbursement will now be negotiated by NW Bio, the hospitals and the Sickness Funds over the coming months, and will be applied to patients case by case. In the meantime, patients may self-pay for DCVax-L.
The approval of the Hospital Exemption for DCVax-L is the culmination of nearly two years of regulatory processes and scrutiny, starting with a Scientific Advice process during 2012, and followed by an application for Hospital Exemption in December, 2012. The evaluation of NW Bio's application by the German regulatory authorities included comprehensive and detailed scrutiny of all aspects of the DCVax-L technology, all DCVax-L clinical data to date, all manufacturing processes, all product characteristics (including potency, composition, sterility and other aspects), all frozen storage of DCVax-L and frozen shelf life, and all distribution and handling of the DCVax-L products.
Although Section 4b of the German Drug law for Hospital Exemptions was implemented in July 2011, the approval for DCVax-L is the first such approval granted by the German regulatory authorities in multiple key ways. Only two prior approvals have been given in the more than 2-1/2 years since the law was put in place, and those were for two German companies with tissue engineered products which had already been on the market commercially under prior laws and were grandfathered for regulatory purposes, and which did not have pharmacological (i.e., drug-like) effects in the patient's body.
In contrast, DCVax-L is the first product of its kind to receive Hospital Exemption approval from the German regulators, in the following key ways:
• the first immunotherapy;
• the first product which exerts pharmacological (i.e., drug-like) effects in the patient's body;
• the first product that has never previously been on the market commercially;
• the first product developed by a non-German company, not previously under the German regulators' oversight; and
• the first "somatic" cell therapy product (a somatic cell is any cell of the body other than a reproductive or embryonic cell).
Furthermore, the scope of the Hospital Exemption granted for DCVax-L is broader than the scope of NW Bio's ongoing Phase III clinical trial (which must focus on a homogeneous set of patients in order to produce data that can be compared between treated and control patients). The Hospital Exemption for DCVax-L applies to all glioma brain cancers, including both the most severe grade (Grade IV, Glioblastoma multiforme or GBM) and lower grade gliomas, while the clinical trial includes only GBM. The Hospital Exemption also includes both newly diagnosed and recurrent gliomas, while the clinical trial includes only newly diagnosed.
Even more exciting are the early results being seen with NWBO’s ongoing DCVax Direct 60 patient PI/II clinical trial for inoperable solid tumors. To date all 9 out of 9 patients who have received 4 of the 6 planned injections are showing tumor cell death, tumor shrinkage, substantial immune cell accumulation in their tumors and/or stabilization (i.e., stopping the progression) of their advanced cancer. In addition, in 3 of these 9 patients, biopsies now show no live tumor cells in the injected tumor.
To date, 20 patients (including the 9 referenced above) have received at least 3 of the 6 total injections, and 13 of these 20 patients are showing tumor cell death, tumor shrinkage, substantial accumulation of immune cells in the tumors, and/or stabilization of their disease. The Company plans to report more details when the patients are further along in the treatment regimen. The first 3 injections are given in the first 2 weeks of the 32-week treatment regimen (at Day 0, Day 7 and Day 14).
So far, 9 of the patients have received 4 of the 6 planned injections, and all 9 of these 9 patients are showing tumor cell death, tumor shrinkage, substantial accumulation of immune cells in the tumors, and/or stabilization of the patients’ disease. The 4th injection is administered in week 8 of the 32-week treatment regimen. (The overall treatment regimen includes 6 injections at Days 0, 7 and 14, and Weeks 8, 16 and 32.)
Also, in a new finding, biopsies taken in 3 of these 9 patients now show no live tumor cells in the tumor that was injected. These 3 cases include diverse, advanced and particularly aggressive cancers: 1 metastatic pancreatic cancer case, 1 metastatic colon cancer case and 1 metastatic sarcoma case. These patients’ tumors show some enlargement on imaging scans, but the biopsies show that live tumor cells are no longer detectable and immune cells are now found there. Each of these 3 patients was treated with the lowest dose level (2 million cells per treatment).
In these 3 patients, as well as the other patients in the trial, only one of their tumors has been injected with DCVax-Direct. The Company plans to inject multiple tumors in its further studies of DCVax-Direct.
One of the patients from this PI/II DCVax Direct trial was recently showcased on the charity fundraiser Stand Up 2 Cancer. The patient is Allan Butler who is the VP of the National Geographic Channel. Allan was diagnosed with Stage 4 Pancreatic Cancer and after 4 months of unsuccessful Chemotherapy he was told that there were no other treatment options left. Below is the link to the clip of Allan’s story.
http://channel.nationalgeographic.com/channel/videos/national-geographic-stands-up-to-cancer/
Allan is now 18 months post diagnosis and feeling great. This is truly remarkable given clinical studies show that 50% of such stage 4 pancreatic patients die within six months and 77% within one year. Perhaps as few as 2-3% survive 18 months.
One last truly remarkable story out of this trial is involves a sarcoma patient with a large tumor mass and multiple inoperable metastatic tumors in the lung. This patient received the first 3 DCVax-Direct injections through the course of a month, starting in February. He received a fourth injection in early April and then was scanned for results in early May. At that time, this patient’s MRI scan showed extensive necrosis and partial collapse of the injected large tumor mass, and a CT scan showed some early indication of shrinkage of one of the non-injected metastasized tumors. These results suggest both local and systemic effects of the DCVax-Direct treatment, as were seen in the pre-clinical studies.
These encouraging results were further supported by tumor biopsies taken at the time of the most recent injection, which showed a high rate of tumor necrosis and appearance of T cells (immune cells) infiltrating into the injected tumor.
Given that Northwest Biotherapeutics is a small cap biotech company, they have literally been exhausting all resources with their trials, German price negotiations, setting up manufacturing infrastructure in Europe etc… What has been lacking is exposure by any media coverage here in the US. I am hoping you will once again take some time to contact this Company as well as Allan Butler and share this potential cancer treatment game changer.
Kind Regards,
Scott Hammons
I think this would be a really good bullet point for a follow up conversation with Senti and Jim Newman
All I got is WOW!!
Pyrr, that is already on my list but thanks for the input!
Thanks for all the input on both the letter to Dr. Siegel as well as my friend who will meet with NWBO on Fri.
Once I have the email/letter put together for Dr. Siegel I will post it here. I will also update everyone with input on the meeting this Friday.
Thanks Senti for posting your conversation with Jim. I still don't buy the innocent Dr. B story. Why would he ever have taken it to the next level as to discuss an investors perspective?? Anyway, it is what it is.
In big at $4.78, $5.22 and going in again today...no real desperation mode on my end
That was my attempt at being cynical zbyte
Here we go...the voice of reason LTT, are you holding long or short position now?
I'm in full desperation mode TiKToK...can I get a hug?
Ditto and thanks for the input! That's why I thought it would make sense to circle the wagon back to him
This was aired back in Nov 13' by Dr. Siegel
I could use input from all of you on this.
I am going to put together an email today for Dr. Marc Siegel at Fox News showcasing NWBO's achievements in both L and Direct, Allan Butler's story as well as the blatant attacks on the Company due to its disruptive technology and be a small fish in a huge ocean. I don't want to spend too much emphasis on the negatives or attacks as I am wanting Dr. Siegel to see the positives.
Any input or guidance would be most appreciated!! I also have a call into Fox News and King 5 News out of Seattle to see if they can air Allan's story on their Health Link section.
For those of you who would prefer to put your own piece together and email Dr. Siegel, his email is marc@doctorsiegel.com. My feeling is one very well written and powerful email will carry more weight than a barrage of emails?
On another note, a good friend of mine down here in Bend has his own investing company. He is in NY for the Rodman Renshaw conference and has a meeting scheduled with NWBO on Friday. His area of specialty is Biotech so he is quite savvy. I have given him some specifics to ask them but any other input is welcomed and I will pass it along. Not sure if we will get any answers out of this but just maybe
GLTA
Nice find Senti. Not sure you got my last post to you?
aka,
Pretty sure I understand "it" and was just simply answering a post by DOK...
Never said I hang out of MB's 24/7 partner? I do follow this particular stock closely though. Never mentioned SCAM in any of my posts?
Appreciate your input but you must have me confused with others
Dok,
I remain very hopeful and realize the significance of Allan's story as well as encouraging direct and systemic effects.
I also am very encouraged by the "rapid progression" arm results. 25% still alive 2-3 yrs...amazing.
I think the overall barrage of attacks has begin to take some effect on my attitude. Probably will just take some time away from following as closely as I tend to. GLTU
Are you still just seeing the slides?
Found the avenue already and on it but thanks anyway!
Will the presentation today be on NWBO's site via webcast?
Thanks for posting these TOB
I'll leave the constant drivel to you my man. Big Hat No Cattle
Thank god for the pills. U still got "the streak" teabaggin' ya on while sprawled on your yacht?
How's the FCEL panning out for ya?
Thnx RedBaron!
I just LinkedIn with Allan Butler. I will keep you posted as I plan on trying to get some more details about how he is recovering as well as media exposure regarding his treatment with Direct as well as the remarkable results.
Chime in if any of you have any other questions you may have for him? I will certainly approach this sensitively!
Senti
I just had the chance to read thru your whole correspondence with MDA/Jim Newman. Great work here and I am in 100% agreement with approaching at this angle as well. There has been zero accountability by MDA for the damage(s) done by the comments of Dr.Buz and their decision to stand 100% behind his statements.
As you know, when this initially occurred, I also was sending frequent emails to MDA but that last for about 2-3 weeks. I certainly can continue to push this issue as well. I was concerned as others were that this might compromise what is left of the relationship btwn NWBO and MDA. Please let me know if you plan on continuing to correspond with Jim/MDA regarding this matter?
Have you or anyone else found a direct contact at CREW or for Melanie Sloan? In reading their filing with SEC, it seems they have a fairly good grasp on the details of AF's attacks. I would like to hear some follow up on this matter and if the SEC has actually looked into this?
On a positive note...as Sitiain mentioned, let's collectively use ALL of our resources to get the Nat Geo/Allan Butler story out there to the main stream media. I would love to see Allan interviewed by FOX or even better by Dr. Marc Siegel! A useful strategy might be for ALL of us to email Marc/Fox and share the Nat Geo link and recommend an interview. Stage 4 Pancreatic Cancer alive and well 18 months post DcVax Direct treatment...truly amazing!! I have media contacts in Seattle whom I am sharing Allan's story with in hopes to get some exposure.
Just some thoughts on how we can use our resources...
Will do, thanks Senti
The other day when he was touting the Nat. Geo video he was certainly be called things worse than Dogwood
Unfortunately his response would be no different from any of his other responses towards positive news/PR from NWBO. AF is a mindless drone that chants the same BS over and over again. The only way we may see a different reaction out of him is when we get full approval but if you look at MNKD and their approval, he continued to beat them down.
Only in our market would you see a company get FDA approval as well as a partnership and the pps still tanks?
austin, I just tweeted the same thing to fukstein
SPOT ON!!
I was stuck in "L Mode" in my head Thanks Smokey!! Already posted on my FB, just looking for awareness. Let's hope our showcase gets some looky loo's tonight and moving forward
My post on my FB page and I recommend we ALL doing something similar.
http://channel.nationalgeographic.com/channel/videos/national-geographic-stands-up-to-cancer/#close-modal
Amazing advances in the treatment of cancer by harnessing your own immune system to recognize the cancer via biomarkers and attack it!! Can you imagine the possibility of no longer having to go through Chemo??
This case highlight with Alan Butler who had stage 4 Pancreatic Cancer which has a 9 month survival rate post diagnosis. Since treatment Alan has more than doubled life expectancy. Treatment was through MD Anderson using a Phase III drug/vaccine called DCVax. The company making this vaccine is Northwest Biotherapeutics, Inc. or NWBO. Web page is web page http://www.nwbio.com/. I encourage everyone to take a look at what this company is doing.
NWBO is making amazing strides in the treatment of Glioblastoma (brain cancer) as well as many other cancers including inoperable cancers. Lets hope we soon see a vast improvement in the current SOC in cancer treatments.
Thank you for posting Rkmatters!! I have some media contacts in Seattle and will be attempting to try and get this out to them.
There have been Red Flags, a lack of transparency at times and what some would say is a CEO who is a "pumper." I for one don't think this is unusual unfortunately for an publicly traded company. For heaven's sake I wish we could get some of these qualities from our own government (cheap shot, sorry).
For BSB, Austin and maybe many others who feel like this is too risky or that as investors the company hasn't been straight with us then maybe reconsidering you exposure would be a good thing? BSB, I can't even imagine the pressure you must feel daily having a 200K position. I had almost 8K and sold 3K of it back at $7.92. I just recently bought back in again at $6.06 and of course wish I had waited but guessing the movement of this stock is close to impossible.
Being a business owner who employs about 35 people I can honestly tell you I am not always transparent with them. Are they invested in me and my company? Absolutely they are. My company is a by no means comparable to NWBO. I can't even imagine the restrictions/limitations of info they are allowed to give to their investors. I also imagine at times, they feel like they are "somewhat" in the dark as well and are sticking to their game plan knowing they fully believe in the science of their vaccines and the anticipated results. Maybe we as investors don't begin to fully understand the position this company is currently in with respect to delivering more information to us?
I personally sat back and read this board as well as YMB for quite some time before finally engaging. This board is at least one in which I think very useful info is being exchanged (at times YMB does as well). I have never taken Pyrr, Flipper, Evaluate, John, Xena, Mav, Long's etc... exchange of dialogue as the Holy Grail but I do appreciate all their work and willingness to share it. Just the same, I appreciate Afford, BSB and Austin's position. I doesn't matter if you are 200K in or 1K in, its money and for most of us, hard earned money!
I for one hate to see some taking things personally here b/c I think this is one of the best boards with alot of truly caring people hoping their investment pays off and most importantly, hoping we can finally kick cancer in the balls hard enough that it can't reproduce
GLTA and I truly hope this works out for all of us investors and patients!
Great post Pyrr! I certainly have not put in as much time as you and many others but...I have put in enough to know that I am quite comfortable with my investment here. I have traded in and out with overall good timing to lower my initial entry point down into the low 6's. I don't contribute much but don't really feel like I need to either b/c I know my timeline and have a plan in place.
As to the work ethic you and many others have and post here on display for you to work thru and us to absorb, I certainly appreciate it. I doesn't sway my decision or overall plan but you certainly have "enlightened" me with many of your posts.
Gotta start previewing my posts..lol
Sorry for the repetitiveness
Most of you have probably already ready this report by Evaluate Pharma..maybe the know something LTT doesn't??
Can't believe NWBO made the top 10 on weak science and expected weak results
Oncology the largest and fastest growing segment
EvaluatePharma® finds that oncology will remain the largest segment in 2020 with forecasts showing an annual growth of 1
1.2% and over
$153bn sales in 2020. Growth from in-line products, and potential new entrants, is forecast to more than compensate for a number of major
patent expiries over the period. Factor Xa inhibitors, Eliquis and Xarelto, are expected to drive a 10.4% annual growth in the anti-coagulant
segment and collectively account for almost $9bn of new sales in 2020. Patent expiries on key products continue to erode sales from anti-
hyperlipidaemics, with this segment falling seven places over the period to 2020
Top 20 Most Valuable R&D Projects (Ranked by Net Present Value)
Sales Oncology the largest and fastest growing segment
EvaluatePharma® finds that oncology will remain the largest segment in 2020 with forecasts showing an annual growth of 1
1.2% and over
$153bn sales in 2020. Growth from in-line products, and potential new entrants, is forecast to more than compensate for a number of major
patent expiries over the period. Factor Xa inhibitors, Eliquis and Xarelto, are expected to drive a 10.4% annual growth in the anti-coagulant
segment and collectively account for almost $9bn of new sales in 2020. Patent expiries on key products continue to erode sales from anti-
hyperlipidaemics, with this segment falling seven places over the period to 2020
Top 20 Most Valuable R&D Projects (Ranked by Net Present Value)
Rank #7 DCVax-L Northwest Biotherapeutics Phase III Cancer vaccine WW product Sales by 2020 ($M)2,046 Today’s NPV ($M)5,502
Not a bad forecast!