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The move down is called "Shaking the Tree." Not geting mine either.
No problem with cap locks. I had really forgotten about the abstract! Thanks again.
Thanks for that reminder... :)
One more for the newbies. I posted this a couple of weeks back, but it went in the ihub black hole that lost posts for 2 days. It again deals with Northwest Biotherapeutics, in immuno-oncology. The CEO at conferences gushes about how wonderful cryogenic shipping is.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=106116070
I have posted this before, so it is a refresher or something for the newbies. I think Cryoport has attracted a lot of new attention recently. This is relative to them being ahead of their time. Immunotherapy is here and thriving!
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=103668730
Dull can be good. I tend to call it "Infrastructure Nuts & Bolts."
The kind of company Warren Buffet made a ton of money on in his career. Just think of all the glitter names,that all need service in their "infrastructure."
Maybe Big Pharma is wrong, and they are starting to realize it.
Someone needs to go to the restaurant to try the food first. For that to happen, someone needs to know about the restaurant and where it is at. Then it spreads by word of mouth. No one finds the place without some sort of advertising, then people discover it and it spreads. This all takes time, no matter how good it is.
A few years ago, very few people heard of Northwest Bio. Now, through their efforts, ASCO booth,(which is constantly whined about here for spending the money), Conferences,(more whining)and multinational trials, (still more whining), the list goes on, and now they are on the radar of a lot of people including Big Pharma.
I don't think this happens if you sit in a corner and develop your product without any advertising.
RK, Maybe this is what he is trying to say:
This, to me, is a very interesting development.
Seems business is picking up.....
http://finance.yahoo.com/news/cryoport-expands-sales-force-address-133000840.html
THE NEWS WE HAVE BEEN WAITING FOR.....
http://finance.yahoo.com/news/transgenomic-announces-q1-2015-launch-130000681.html
Just sending shipments to these companies, will introduce them to the convenience and reliability of the shipper. The more people are exposed, the more they realize how good the product is. I really expect the DHL contract to do good things for them. I asked a DHL delivery guy if they deliver any dry ice shipments. He replied they do a lot, all international. It may take the Germans a while to get up to speed, because they are so meticulous, but when it goes it's gonna go big!
My thoughts also. Even types on the left side of the page like him.
Senti,
When you get sick of hearing it over and over and over, just hit the ignore button! Makes reading this board so much nicer, without all the whining! And a lot faster......
I would also think there is still tax loss selling involved here.
Regarding cryogenic shipping,I think you hit the nail on the head with Cryoport. This is an upstart in the sector, which some call the "Cadillac of cryogenic shipping. I would think Cognate is using them because they have inked deals with the big 3 shippers, DHL, UPS, and Fed Ex.. The Cognate facility is right next to the major world-wide hubs of Fed Ex and UPS. The reason i go here, is because I have a short video made by Fed Ex, which will give you quite an insight into how these vaccines are shipped. It also gives you a quick look at R2D2 at about 1 minute.
You are probably right about the timing of the price. The big thing to me is that he did not demand a price up to 25% below the market. Or he did not short it down to there. Also, it was done without warrant coverage. This tells me he is extremely confident about the prospects of Northwest Bio.
Great Stuff, Thank you!
Would you like one "lump" or two? :)
That very well maybe, but the bigger point was this:
More often than not, Phase 3 drugs sell for Phase 1 prices.
Two Simple Ways to Spot Hidden, Undervalued Biotech Stocks
By Thompson Clark
Thompson Clark
Last week, I attended a fairly exclusive investing conference. And while there, I had a fascinating one-on-one conversation with a whip-smart CEO of a biotech company. He has his Ph.D. in mechanical engineering. So you know this guy knows what he's talking about.
He gave me two ideas that might generate some big biotech profit opportunities in the coming months. What he said really kicked my brain into gear.
Let me explain why...
See, the crazy thing is this CEO considers himself a value investor. Now, if you know much about biotech investors, that sounds ridiculous.
Biotech stocks can swing wildly -- anywhere from 25-75% overnight. You take some big gambles.
But value investing is the opposite. Value investors like us find hidden treasure in the stock market. They find million-dollar houses selling for half off.
So how could this CEO consider himself a value investor? That's exactly what I asked myself.
The further along the company is in these phases, the more it should be worth.
As we talked more, it started to come together for me... a light bulb went off in my head.
It has to do with how people misprice the value of drugs getting FDA approval.
A company goes through four phases with the FDA to get drug approval. It's during these phases researchers prove the drug works. Each phase is harder and harder to pass. The goal is to pass all the steps and get FDA approval. Once approved, the company can sell the drug and get rich!
The further along the company is in these phases, the more it should be worth.
But here's the kicker.
More often than not, Phase 3 drugs sell for Phase 1 prices.
Now, my CEO friend gave me the rundown on these phases. What you need to know is once a company reaches Phase 3, as he explained, approval is almost guaranteed. But unbelievably, the market sometimes fails to account for this. The stock could be in Phase 3 -- yet "valued" like it's in Phase 1
In other words, we're buying a potential bar of gold for the price of a lump of coal.
Now, that's exactly the type of opportunity I'm on the lookout for.
But this guy gave me another idea that really set my wheels in motion. He explained that there are plenty of cases where a few different companies are researching the same drug, trying to solve the same problem. Company A could trade at $100 million, while Company B could trade at $1 billion. And yet they're solving the same problem.
This is a textbook example of market inefficiency.
And as it turns out just a little bit of research can help sort this out. What if Company A has worse results in drug studies? Then the gap might make sense. Or what if Company A is in Phase 1 with the FDA, while Company B is in Phase 3? The price gap would make sense as well.
Most stock buyers don’t understand how to value a biotech company.
However, there are many cases where it's the exact opposite. Company A -- the cheaper of the two -- will have a better drug and higher degrees of FDA approval. But it will trade at a huge discount to Company B.
How's this possible?
Most stock buyers don't understand how to value a biotech company. So the companies that promote themselves can do really well at first, while the quieter, science-based companies are hidden treasures Wall Street doesn't have on its radar.
Basically, after a company is approved for Phase 3, you'd think everyone would be excited. But the truth is a lot of these Phase 3 companies slip completely off everyone's radar because they don't have a slick-talking CEO to promote them.
And that's great news for us.
Situations like this can hand us enormous profits -- safely. We'll want to invest with the smart guys and avoid the promoters. This gives us limited downside and potentially unlimited upside. And you can take this to the bank -- I'll be spending a lot of time sniffing out these opportunities for you in the months ahead.
I'll keep you in the loop as I do my detective work.
Regards,
Thompson Clark
for The Daily Reckoning
Etienne, you are welcome. The entire article is a good read, as it sheds some light on the vast strugggles of Northwest Bio. It also sheds light on the vision of Linda Powers, and on the roles that Toucan Capital, Cognate Bioscience, and Dr Liau and UCLA played in the formation of the vaccine that we all hope will become the SOC for cancer.
http://smithonstocks.com/northwest-biotherapeutics-dcvax-cancer-vaccines-may-be-a-game-changer-in-cancer-therapy-nwbo-0-22/
From Smith on Stocks:
http://smithonstocks.com/northwest-biotherapeutics-dcvax-cancer-vaccines-may-be-a-game-changer-in-cancer-therapy-nwbo-0-22/
Northwest Biotherapeutics was founded in 1996 by Dr. Alton Boynton, the current chief science officer. He is credited with being the first person to conduct a clinical trial with dendritic cell cancer vaccines. During the 1990s, he treated over 100 prostate cancer patients in academic settings using technology that became the basis for the company’s DCVax technology platform. Prior to founding NWBO, he headed the molecular oncology research laboratory at Northwest Research Foundation, a predecessor to the Fred Hutchinson Cancer Center in Seattle.
The company came public in December 2001 in an offering that raised $20 million and valued the company at $100 million. The offering was made at a time when a biotechnology financing window was rapidly closing and the money raised was insufficient relative to the burn rate of the company. The company had hoped to come back to the equity market quickly feeling that data generated with its dendritic cell vaccine DCVax Prostate would be recognized by the market as significant validation of the technology, boost the valuation and allow the company to raise the capital needed to fund the company and conduct a phase III trial.
The company was unfortunate because by the end of 2002 the equity market was shut down for biotechnology financings. It was fast running out of cash and the stock price dropped sharply. NWBO failed to meet the minimum requirements of the NASDAQ National Market and was delisted resulting in relisting on the OTC bulletin board. This unfortunate financial beginning put the company on a tortured path that has lasted for a decade. Plagued by the stigma of being a bulletin board company, limited resources and low market valuation, it struggled to attract capital to keep development plans alive. NWBO was on the verge of insolvency by 2004 when Linda Powers, head of the Toucan venture capital funds, made a series of investments that allowed the company to continue its development efforts; Toucan went on to become the major shareholder.
At the time the company went public its focus was on developing DCVax-Prostate based on encouraging data that it had accumulated in phase I and II trials. In January of 2005, FDA Clearance was received to conduct a phase III trial in prostate cancer with DCVax-Prostate. The phase III was planned to be a double blinded, placebo controlled trial enrolling about 600 patients at 30-50 sites in the United States. However, a trial of this size was beyond the financial capability of the company to fund.
Northwest was concurrently developing a second product, DCVax-L, a dendritic cell vaccine for glioblastoma multiforme or GBM. In 2004, Northwest began a collaboration with investigators at UCLA who conducted two phase I trials for DCVax-L. The trials evaluated safety and efficacy in 20 newly diagnosed GBM patients and 9 recurrent GBM. The initial data from these trials was very impressive and DC Vax-L became the principal focus of the company. The impressive data along with the potential for a smaller, easier to fund trial were the primary factors in the decision. DCVax Prostate was put on the shelf until its phase III trial could be funded.
Alan Butler looks to be awake in the video with the needle sticking up out of his midsection....Maybe some sort of local anesthesia?
I don't know, AF uses their name all the time. I they had to choose........
Here is an interesting company that is quickly bringing to market a "Blood-Biopsy."
Transgenomic, Inc. (TBIO), a global biotechnology company advancing personalized medicine in cardiology, oncology, and inherited diseases through diagnostic tests as well as clinical and research services, today announced that the U.S. Patent and Trademark Office (USPTO) has issued a new patent related to its licensed ICE COLD-PCR technology. The patent, titled “Full cold-PCR enrichment with reference blocking sequence”, was assigned U.S. Patent No. 8,623,603 and is set to expire in 2031.
“This newly issued patent significantly strengthens our intellectual property portfolio and further supports the ongoing development of this cutting-edge technology that has the potential to revolutionize cancer screening, diagnosis, monitoring, and treatment selection, as well as replacing the need for biopsies and reducing this massive cost to the healthcare system,” said Paul Kinnon, President and Chief Executive Officer of Transgenomic. “We intend to leverage this proprietary asset immediately in both our patient testing business and with our pharmaceutical and biotechnology client companies, the primary market for ICE COLD-PCR, especially those looking for low level mutations in blood. A strong patent position is at the core of our business model and strengthens our competitive advantage in the marketplace.”
The new U.S. patent extends the scope and longevity of the COLD-PCR intellectual property portfolio. The '603 patent covers ICE COLD-PCR methods for enriching low abundance alleles in nucleic acid samples. It is directed in particular to the use of an excess amount of reference blocking sequence in an amplification reaction mixture in order to improve the enrichment efficiency, and reduce cycle time, of full COLD-PCR. The new patent reinforces Transgenomic's ICE COLD-PCR technology platform alongside its other high sensitivity mutation detection technologies, such as SURVEYOR® Scan and BLOCker™- Sequencing. Originally developed by the Makrigiorgos laboratory, the '603 patent is owned by the Dana-Farber Cancer Institute and licensed to Transgenomic.
About ICE COLD-PCR
ICE COLD-PCR (Improved and Complete Enrichment COamplification at Lower Denaturation temperature) technology was originally developed by the Dana-Farber Cancer Institute and is supported by multiple validation studies confirming reproducible mutation detection at very high sensitivity. It selectively amplifies mutant DNA by exploiting differences in denaturation temperatures between mutant/blocker DNA duplexes and wild-type (normal)/blocker DNA duplexes. ICE COLD-PCR is able to detect mutant DNA occurring in as low as 0.01% frequency in a majority of wild-type populations which results in 100-400 fold improvements in detection limits. ICE COLD-PCR is ideal for standard Sanger sequencing, next generation sequencing, digital PCR and other technologies.
The ICE COLD-PCR technology is not specific to a single mutation within a DNA target but enables detection of any mutation in a given region of DNA. This approach allows clinicians to use small amounts of sample for genetic analysis or non-invasive sample collection methods (e.g., a blood draw) to enable detection of mutant DNA species present in serum or plasma, circulating tumor cells, urine, or bronchial lavage specimens. DNA can also be analyzed from fine needle aspirates, core-biopsies, or directly from tumors. Since ICE COLD-PCR can detect low level mutations in samples where an abundance of “normal” DNA exists, such as blood, repeated assessments of a patient’s disease status can be determined without having to take additional biopsies from the tumor.
Very well said....The science is what matters, and of course that the Germans also believe in it
Gilead's experimental drug fails mid-stage study
Reuters
3 hours ago
(Reuters) - Gilead Sciences Inc said its experimental drug did not significantly improve how long patients with a type of pancreatic cancer lived without the disease worsening.
The mid-stage study evaluated the drug, simtuzumab, in combination with chemotherapy, against a placebo plus chemotherapy, in previously untreated patients with advanced pancreatic cancer.
The study failed its main goal of improving progression-free-survival (PFS). There was no statistically significant difference in PFS between patients on simtuzumab and those on the placebo, Gilead said on Wednesday.
Simtuzumab is also being tested for use in colorectal cancer, myelofibrosis, idiopathic pulmonary fibrosis and liver fibrosis.
Last week, Gilead said the next generation version of its $84,000 hepatitis C drug, Sovaldi, already under fire for its record-breaking costs, was going to be even more expensive.
Separately, the biotechnology company also licensed Sovaldi to seven India-based drugmakers that will sell far cheaper versions of the drug in 91 developing nations.
Foster City, California-based Gilead's stock was little changed at $105.14 in premarket trading on Wednesday. The stock closed at $104.76 on Tuesday.
NW BIO'S CANCER VACCINE IS THE FIRST DRUG TO BE DESIGNATED BY UK AUTHORITIES AS A "PROMISING INNOVATIVE MEDICINE" (PIM)
"PIM" Designation For DCVax-L Is First Step In 2-Step Process for Early Access Approval
PR Newswire
Northwest Biotherapeutics 7 minutes ago
BETHESDA, Md., Sept. 16, 2014 /PRNewswire/ -- Northwest Biotherapeutics (NWBO) ("NW Bio"), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced today that its DCVax-L is the first product to receive formal designation as a "Promising Innovative Medicine" (PIM) under the new "Early Access to Medicines Scheme" (EAMS) launched in the UK in April 2014. A PIM is the first step in a 2-step process for early access approval under the EAMS.
View photo
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Northwest Biotherapeutics Logo.
The PIM designation for DCVax-L covers all malignant gliomas, which would include both Glioblastoma multiforme (the most severe grade) as well as less malignant grades, and would include both newly diagnosed and recurrent gliomas.
The EAMS is an important new initiative in the UK, launched by the Medicines and Healthcare Products Regulatory Agency (MHRA, the FDA of the UK), to lead the way in accelerating patients' access to innovative new medicines for serious diseases. Information about the EAMS program can be found on the MHRA website at: http://www.mhra.gov.uk/Howweregulate/Innovation/EarlyaccesstomedicinesschemeEAMS/index.htm
The first step under the EAMS is MHRA's scientific evaluation of whether a product candidate meets three criteria for a PIM designation: (i) the product is for a serious disease or condition with high unmet medical need; (ii) the product is likely to offer a major advantage over treatments available today; and (iii) the potential adverse effects of the product are outweighed by the potential benefits.
NW Bio's DCVax-L has now become the first product to earn this PIM certification. There is no expiration on the PIM certification.
The second step under the EAMS is MHRA's determination of a Scientific Opinion about the product candidate's benefits and risks, based on available clinical data. A positive or negative Scientific Opinion will be judged by the same three criteria as for the PIM designation, as well as a fourth criterion: the Company's ability to manufacture the product to rigorous "GMP" (clinical grade) standards.
If the Scientific Opinion is positive, the product candidate may then be prescribed by physicians and provided to (and paid for by) patients before the product is formally licensed and while it is still in clinical development.
MHRA aims to deliver the Scientific Opinion within 90 days after a party submits an application for Step 2 of the EAMS process.
In granting the first PIM designation under this new EAMS to DCVax-L, the UK Department Of Health has stated, "An innovative cell therapy for cancer has become the first to be certified as 'promising' as part of a new Government scheme aimed at getting new medicines to patients quicker.
The medicine, which has been developed by US-based pharmaceutical company Northwest Biotherapeutics Inc. (NW Bio), is the first drug to be awarded the UK's new Promising Innovative Medicines (PIM) designation, the initial step in the Early Access to Medicines Scheme which aims to increase patient access to unlicensed treatments."
UK Life Sciences Minister George Freeman noted that "The designation of the PIM is the first, crucial step in developing cutting-edge medicines sooner, giving real hope to patients and their families."
Dr. Keyoumars Ashkan, a senior neuro-surgeon at Kings College Hospital in London, and the Principal Investigator for the clinical trial of DCVax-L in the UK, commented that "Brain cancers strike patients of all ages, and are rapidly lethal. New treatment options are urgently needed. DCVax-L offers an exciting new approach to treating these brain cancers, through personalized immune therapy. It is encouraging to see this innovative new product be the first to receive certification as a Promising Innovative Medicine under the new EAMS."
Linda Powers, CEO of NW Bio, commented that "We are most grateful to the MHRA and Minister Freeman for spearheading this new EAMS. It strikes a very practical balance between clinical benefits and risks, through careful scientific evaluations, and will be of great help to doctors and patients in opening up new treatment options."
"In prior Phase I/II clinical trials of DCVax-L for brain cancer, significant delays in disease progression and significant extensions of patients' survival have been seen, with virtually no serious adverse effects," Ms. Powers continued. "We believe that DCVax-L embodies the combination of innovation and beneficial balance of clinical benefits and risks that the EAMS is designed to accelerate. We are excited that DCVax-L has received the first PIM certification."
About Northwest Biotherapeutics
Northwest Biotherapeutics is a biotechnology company focused on developing immunotherapy products to treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and on a cost-effective basis, in both the United States and Europe. The Company has a broad platform technology for DCVax dendritic cell-based vaccines. The Company's lead program is a 348-patient Phase III trial in newly diagnosed Glioblastoma multiforme (GBM). GBM is the most aggressive and lethal form of brain cancer, and is an "orphan disease." The Company is under way with a 60-patient Phase I/II trial with DCVax-Direct for all inoperable solid tumors cancers, with a primary efficacy endpoint of tumor regression. It has completed enrollment in the Phase I portion of the trial. The Company previously received clearance from the FDA for a 612-patient Phase III trial in prostate cancer. The Company conducted a Phase I/II trial with DCVax for metastatic ovarian cancer together with the University of Pennsylvania. In Germany, the Company has also received approval of a 5-year Hospital Exemption for the treatment of all gliomas (brain cancer) patients outside of the clinical trial.
Flip,
Great work as always!
I am convinced AF was hand fed Budzar's name, from the same companies that fund MD Anderson to the tune of hundreds of millions of dollars per year. If you are MD Anderson, are you going to worry about a small biotech that may or may not be successful, or worry about the monied interests that keep your doors open. The whole conversation was a setup. Big Pharma stands to lose hundreds of billions if Northwest is successful. Linda has everything structured so that she can give Big Pharma her middle finger until they reach her price and her conditions. There only hope is to try and starve Northwest, and at the same time keep the price down. This is why the capital raises are so telling. There is no problem raising money, even with all the negative sentiment. If the drug is as good as Pyrr believes, she may never sell. Sorry BSB, but you can buy a yacht if you wait!
I have posted before about the fact that a large percentage of the new drugs coming available over the next few years will have to be cryogenically frozen. I am an investor in Northwest Biotherapeutics,
which has a so far, very promising cancer vaccine. Anyway, as an investor I was listening to their presentation at Rodman Renshaw and found this quote fascinating for this board:
I think it has to do with AF and MD Anderson. The last time this information was revealed, it was blasted off the face of the earth by the usual people and Dr Buzzard. This time it is at a conference, with no PR, and if you hear about it you are aware and looking for it. Now all the good information is available, and LP thinks there will be no backlash. We shall see, I certainly hope there is none.
I think it is up to the big three to move people in Cryoports containers. My take is Cryoports dewars are a whole lot easier, a lot greener, and substantially cheaper to use.
If the big three are going to get away from dry ice, they need to push their customers to this solution. It is easier for everyone involved. As I stated in an earlier post, a large part of the new drugs coming to market in the next 5 years will have to be cryogenically shipped. I think the big three would love to get away from dry ice and into just shipping boxes with an awfully cold dewar inside...
Pick any number you want, I think you get my point! We are talking billions here, and we are fretting over 17.5 million.
We all want financing for nothing. Unfortunately, that will NEVER happen. If LP were to partner for 100 million, there would be naysayers saying that she gave away the company. There will always be problems for some. Financing is a necessary evil for any public company, and biotechs burn through it pretty quickly, especially during trials. If we can't stand the heat, and we don't like the way things are being done, then you are overexposed, and you need to sell some or all of your position.
UPS would indeed be a positive. I am wondering though, what it would do for the share price? DHL, the largest shipper in the world did not move the needle, although something is to be said for the confidence of the top 3 shippers in Cryoport.