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Swine Flu News Concentrator (February 12 - March 13) 98 comments
I will post Swine-Flu and related articles under this heading. The top of the instablog will contain my current months key links preceded with a one or two liner that explains the link. A more complete summary of the link will be in the comments area. At the bottom of the Instablog we have definition of terms, a summary of Swine Flu / vaccine investment plays, the 2009 H1N1 Flu Outbreak Map, Red Cross Tips For Dealing With The Flu, and Memory Alpha which contains links to previous news concentrators and authors articles on the subject.
I will be backing this up as well.
Last backup: February 12, 2010
_____________________
Update History:
Added definition of Reassortment
Added definiton of R0 (R Naught)
Added Overview of H1N1 / Categories of Vaccine Investment Plays Added Memory Alpha
Added Link to Google's Swine Flu Infection Map
Added Red Cross Tips for Dealing With The Flu
Added definition of EUA and PREP act
Broke Swine Flu Concentrator into two parts for October
Broke Swine Flu Concentrator into three parts for October
Added Swine Flu Concentrator November Part 1
Bolded References to Older Swine Flu Concentrators in Memory Alpha
Expanded the list of stocks discussed in the tags
Alphabetized stocks in the tags
Updated the play by stock list
Added a table that contains the web site addresses for the companies discussed
Moved links over one month old to the new Memory Alpha Reference Library
Added definitions of Clinical Trials and Protocol.
Corrected Roche stock symbol in the web site table
_____________________
January Links:
Swine Flu News Concentrator January 25 to February 12
http://preview.tinyurl.com/yjccho4
___________________
Some Definitions:
What is Reassortment
When two different virus strains infect the same host, they often exchange genes, a process known as reassortment.
A significant number of experts are concerned that as H5N1 (Avian Flu) spreads more widely and infects more people, it will come across more hosts who are also carrying human flu viruses. This increases the likelihood of a new strain emerging that has the severity of the bird flu virus and the infection rate of the swine flu virus, leading to a new global pandemic with much deadlier consequences than the one we are experiencing at the moment.
What is R naught (R 0)
How many people the average infected person infects is called the basic reproductive number, or R0 (pronounced "R naught").
Measles, which is probably mankind's most contagious infection, has an R0 of about 18. Polio's number is about 6; severe acute respiratory syndrome (SARS) about 5. For seasonal flu strains, the R0 is about 1.2, and for pandemic strains it is rarely higher than 2. For the novel H1N1 strain, it's about 1.6. What this low R0 means is that flu outbreaks are always teetering on the verge of having their myriad chains of transmission broken by people who get infected but don't pass the virus to anyone else.
Swine Flu - Novel H1N1 flu, popularly known as swine flu, is a respiratory infection caused by an influenza virus first recognized in spring 2009. The new virus, which is officially called swine influenza A (H1N1), contains genetic material from human, swine and avian flu viruses. (By Mayo Clinic staff)
Pandemic - The word "pandemic" comes from the Greek "pan-", "all" + "demos", "people or population" = "pandemos" = "all the people." A pandemic affects all (nearly all) of the people.
A World Health Organization phase 6 pandemic indicates that influenza due to the novel H1N1 swine flu is occurring in multiple countries around the world and that human infection is widespread. The classification does not reflect the severity of individual infections.
Cytokine Storm -
When our body detects foreign micro-organisms indicating an infection, our body might respond by over-protecting the site of infection. The body may race so many antibodies to the infection site that they collect in what is known as a cytokine storm.
A cytokine storm, or "Hypercytokinemia" is a potentially fatal immune reaction consisting of a positive feedback loop between cytokines and immune cells.
www.wisegeek.com/what-is-the-cytokine-st...
A positive feedback loop means that as something increases, that increase stimulates further growth.
What makes younger people more susceptible to H1N1 is that their “vigorous immune systems pour out antibodies to attack the new virus. That can inflame lung cells until they leak fluid, which can overwhelm the lungs.
This vulnerability in the young is reminiscent of the Spanish flu of 1918. That strain of flu also struck mostly healthy young adults.
Pulmonary Embolism - Occurs when a blood clot forms in an arm or leg breaks free and enters the lungs where it is too large to pass through the small vessels of the lungs and forms a blockage. This stops blood from flowing into an area of the lung, and the part of the lung dies because it does not receive oxygen.
medicalnewstoday.com/articles/153796.php
What is an Emergency Use Authorization (EUA)?
An EUA may be issued by the Food and Drug Administration (FDA) to allow either the use of an unapproved medical product or an unapproved use of an approved medical product during certain types of emergencies with specified agents.
What is the PREP Act?
The PREP Act authorizes the Secretary of the Department of Health and Human Services (“Secretary”) to issue a declaration (“PREP Act declaration”) that provides immunity from tort liability (except for willfull misconduct) for claims of loss caused, arising out of, relating to, or resulting from administration or use of countermeasures to diseases, threats and conditions determined by the Secretary to constitute a present, or credible risk of a future public health emergency to entities and individuals involved in the development, manufacture, testing, distribution, administration, and use of such countermeasures.
The PREP Act also authorizes an emergency fund in the United States Treasury to provide compensation for injuries directly caused by administration or use of a countermeasure covered by the Secretary’s declaration. While no funds have been appropriated for this purpose, if funds are appropriated, compensation may then be available for medical benefits, lost wages and death benefits to individuals for specified injuries.
cdc.gov/h1n1flu/eua/qa.htm
What are Clinical Trials:
Clinical trials, also known as clinical studies, are research studies in which scientists and doctors test new drugs and treatments to see if they will improve health. Many of today's treatments for cancer are based on the results of past clinical trials. Because of progress made through clinical trials, many people treated for cancer are now living longer.
Clinical trials are divided into four phases.
Phase 1 trials: These trials are the first time a new drug or treatment is given to humans. They are normally carried out in a small number of volunteers (typically 6-20 people) who may include healthy volunteers or patients with the disease for which the product is intended as a treatment in order to find out how safe the treatment is. They also look at how a new drug should be given (by mouth, injected into muscle or the bloodstream, etc.), how often and at what dose. Phase 1 trials can also involve patients for whom standard therapies have failed and for whom no other therapies are available.
Phase 2 trials: These trials involve larger numbers of people (typically 12 - 50). Phase 2 trials continue to look at safety of the therapy but also test how well the new drug or treatment works in patients with different disease types.
Phase 3 trials: These are large studies (100+ people) that look at how well a new drug or treatment works in comparison to current therapies to see which treatment is better. Those taking part are usually divided into two treatment groups: standard treatment versus new treatment.
Phase 4 trials: These trials are usually carried out after the drug or treatment has been approved by the FDA and is readily available for use in the general patient population. The purpose of Phase 4 trials is to continue to study the effects of the drug or treatment on different populations and to look for side effects associated with long-term use.
Back to Top
What is a Protocol:
Clinical trials use written guidelines called protocols. The protocol explains what the trial hopes to accomplish, how the trial will be carried out, and why each part of the trial is necessary. For example, the protocol includes:
* The reason for doing the trial
* How many people will be in the trial
* Who is eligible to take part in the trial
* What study drugs participants will need to take
* What medical tests participants will have and how often
* What information will be gathered
Every doctor or research center that takes part in the trial uses the same protocol. This makes sure that patients are treated identically no matter where they are receiving treatment, and that information from all the centers taking part can be combined and compared.
Why Slow Production for Traditionally Produced (chicken eggs) Swine Flu Vaccine:
One dose of swine flu vaccine for every two eggs, compared with two doses of seasonal flu vaccine per egg
http://www.boston.com/business/healthcare/articles/2009/10/22/quest_for_swine_flu_vaccine_giving_some_firms_a_boost/
_____________________
Brief Overview of Categories of H1N1/ Vaccine Investment Plays:
I - Vaccines / Prevention
1) Production Method / Capacity plays (NVAX) (VICL) (NVS) (INO)
2) Nationalistic / Population Size Play (SVA - China) (NVAX - India)
3) Injection / Vaccine support services (syringes etc.) (BAX) (BDX)
4) Outsourced production plays
5) Bio -Defence (MDCGF - France)
6) Anti-Mutation / Pan-Influenza Play (CVM) (NNVC) (INO)
7) Universal Flu Vaccine Play (INO)
II - Treatment After Infection Occurs:
1) Dealing with severe lung infections (Fludase® (DAS181)) (CBM) (AEMD)
2) ICU treatments (BCRX) (GSK) (ROG)
III - Population Avoidance:
1) masks/ disinfectants… Surgical masks are good enough (APT) (MMM) (CLX) (ECL) (PURE)
IV - Testing do you have it? (GPRO)
1) Test kits - (DGX)
V - Merger / Acquisitions / Licensing (VICL) (NVAX)
_____________________
Sorry this is still a graphic instead of a table. I played with the table tool, but its a
PITA to work with.
Swine Flu Companies Discussed and Their Web Sites
_____________________
Swine Flu Hits Stuffed Animal World:
2009 H1N1 Flu Outbreak Map:
The Link is from DoubleGuns
flutracker.rhizalabs.com/
I am not too happy with any of the outbreak maps. They all make the same mistake, they try to show the worlds data on one chart. This makes them SLOW.
I will keep looking for one that works faster.
_____________________
Red Cross Tips For Dealing With The Flu:
IF YOU ARE ILL -
* Stay in a room separate from common areas of the home and avoid contact with others as much as possible.
* Stay at home for at least 24 hours after their fever is gone without using medicine to reduce the fever.
* Get lots of rest and drink plenty of fluids.
* Consider wearing a facemask, if available and tolerable, when sharing common spaces with household members. (ed - surgical masks ok).
* Check with your healthcare provider about whether to take antiviral medication, or if fever persists, whether antibiotics are needed.
WHEN CARING FOR SOMEONE WHO HAS THE FLU -
*Disinfect door knobs, switches, handles, toys and other surfaces that everyone touches.
* Use detergent and very hot water to do dishes and wash clothes. It's okay to wash everyone's dishes and clothes together. Wash your hands after handling dirty laundry.
* Designate only one adult as the caregiver. People at increased risk of severe illness from the flu should not be caregivers.
* Although not mentioned by the Red Cross, the caregiver should probably ware a surgical mask as well when entering the sick room.
* Deal with crisis situations calmly and confidently to give the best support to the person being cared for.
_____________________
MayoClinic.com Provides Credible, Up-to-Date Information And Decision-Support Tools For Flu Season
Click here to link to the Mayo tool:
www.mayoclinic.com/health/flu-symptoms/F...
_____________________
Suggeted Protocol For Schools To Decide When Flu Should Trigger A Shutdown
www.medicalnewstoday.com/articles/169984.php
After comparing more than two dozen possible scenarios for closing a school, the analysis suggested three optimal scenarios:
1. A single-day influenza-related absentee rate of 5 percent
2. Absenteeism of 4 percent or more on two consecutive days
3. Absenteeism of 3 percent or more on three consecutive days
Older references are stored in the MEMORY ALPHA REFERENCE LIBRARY
http://seekingalpha.com/instablog/283977-user-283977/37565-memory-alpha-reference-library
Disclosure: NVAX, NNVC, SVA, VICL (sometimes trading, sometimes holding)
Instablogs are blogs which are instantly set up and networked within the Seeking Alpha community. Instablog posts are not selected, edited or screened by Seeking Alpha editors, in contrast to contributors' articles.
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This post has 98 comments:
Next (but not most recent) resistance ~$2.50.
YEE-HAW!
HardToLove
"Our DNA delivery technologies may be useful in developing vaccines for infectious diseases, in which the expressed protein induces an immune response; novel therapies for cancer, in which the expressed protein is an immune system stimulant or tumor suppressor; and therapeutic protein delivery, in which the expressed protein is a therapeutic agent"
(VICL) could fit that bill, User, right enough. But I suspect they are talking about a teensy penny company somewhere.
(CVM) is still tracking along at .53, going nowhere fast. Tracking...
NVAX is continuing up; influenced maybe this upcoming conference? Same with VICL. This could be a trade?
HardToLove
HardToLove
I am tired of seeing my investment profits drained off by short market parasites who sell stock they don't own in order to drain off gains in the investment rightfully belonging to investors that purchased the stock based on future earnings potential.
I do intend to place long bets on NVAX and VICL, but not right now.
My interpretation is that someone is trying to hold down the price: lunch time is an excellent time to try these things because volume lightens up then, a lot of pros are out to lunch and skittish retail buyers are probably the majority of the folks active at that time.
All my *suppositions* derived from watching, trying to learn "why" and thinking. I guess I'm a junior "Sherlock" here - lots of deductions based on skimpy clues.
HardToLove
I just went over a chart of the volume, its interesting.
I threatened to buy in this morning and now I'm sad I didn't. Sometimes the turtle carapace chaffs.
HardToLove
HardToLove
xml.10kwizard.com/fili...
Wellington is a financial advisor to institutions, so this could be pretty interesting to say the least.
HardToLove
These results may help NVAX get at least part of the BARDA grant money they applied for last year - hopefully enough to fully fund Phase 3 testing in the U.S. at the end of this year.
NVAX didn't come out and issue a PR when these results became available, but presented the results to the WHO instead.
I think we'll see an order from Mexico shortly, and possibly some other ex-U.S. countries based on these test results. I believe NVAX stated some time ago they were planning on getting Mexico approval in Q110 and start selling in Q2 - looks like they are on track. The India plant is scheduled to open towards the end of March...it appears to me that NVAX is getting very close to start selling some vaccines. Stock looks awfully cheap down here at this point. Thoughts/comments anyone?
clinicaltrials.gov/ct2...
But short interest has been very high. I'm getting ready to add this week's report to my charts and will post a little update tonight.
I also forward them to User, who has the analytical skills to notice things that I might not, and maybe he'll have something to add tomorrow.
HardToLove
I expect we'll see a PR very, very soon. Looks like we are moments away from having a marketable product - finally!!
messages.finance.yahoo...
Avimex Laboratories is the company that NVAX is partnered with for the H1N1 Clinical Trials in Mexico. If the results are clinically acceptable, they will be used to seek registration of NVAX H1N1 vaccine in Mexico. That data will also provide support for the companies H1N1 and seasonal flu vaccines in other countries. The 500 pound gorilla that we want is India, where NVAX has a manufacturing partner already in place. Keep your fingers crossed and thanks for the post!
www.avimexlabs.com/inn...
So how close do you think we are to releasing/selling based on this prescribing info?
From the WHO presentation, looks like NVAX has met the requirements to sell outside of the U.S.:
- Immunogenicity responses at all dose levels meet U.S. and European regulatory authorities recommended criteria for seroconversion and seroprotection
Looks like it might make $2.39-$2.40 (high so far $2.42) again today, but that should be about it unless someone big is waiting to buy at the close - I've seen some of that.
I'm guessing volume today <= ~950K. This doesn't indicate it's going to reverse, may be a start of a consolidation.
HardToLove
Maybe consolidation won't start as soon as I was thunking next week.
Oh well, I've eaten enough of your time on this - going silent on it for a while (couple days?).
HardToLove
Either we had a really enthusiastic believer in there or the shorts have really started sweating bullets now. That was 13.7% of the day's volume in 7 minutes.
I completed my round trip @ $2.39 and still have a good core of 3.3K shares among the 3 accounts with a better cost-basis again.
HardToLove
Maybe I'm misunderstanding what's being laid out here?
HardToLove
I'm too ignorant (in the best sense of the word if there is such a thing) to make an educated guess.
But having said that (and being never loathe to display my degree of ignorance), it's certainly possible. But it adds an element of risk that I wouldn't want to contribute if I was long that much. If I short directly, I tend to suppress the price by doing so - bad for my long side. But I could also do it with an eye to picking up more shares on the cheap. At the same time I decided I should cover, certainly an attractive price point, I could also buy a boatload more at a cheaper price. This would be a decent plan if I believed the long-term story was good and I wanted to "hedge" by increasing my holdings at a substantially reduced price.
The risk, of course, is that if I'm too aggressive, I've created a self defeating scenario.
Since I know nothing about the company, I can't guess if they would be likely to do this.
Someone who knows the companies profile and history would be a better source.
I'll only add that if they are a conservative company, they should be unlikely to engage in this sort of strategy because of the risk it adds. I would think that a better hedge, if that's what they wanted to do, would have been to buy LEAPS (long-dated) puts while the stock was at a high price or buy another offsetting instrument that gains value if the stock drops
I've been thinking about the mechanical aspects of the put writers and have theorized that when we buy puts we (unknowingly) cause a short in the market. I've yet to find the literature that would confirm this, but here's how I'm guessing, for now, that it works.
If I write a put, when someone buys my put I'm immediately at risk. So a logical action would be to short the underlying at or higher than the current price. I've brought in the premium plus the proceeds from the short sale. This revenue can be used many ways to generate revenue until the put is exercised. At the appropriate time, I can cover the shorts if the put is exercised with the shares from the put. Being an astute market person (if I'm doing this stuff I *need* to be) I'll probably know in advance if the exercise is likely or not. Anyway, I can also cover the shorts when the market price is advantageous to me.
That's my theory and I'm sticking to it until I acquire real knowledge of the process. ;-))
HardToLove
Of course, it shocks me how often people (even those living off their investments) are ignorant of the Tax changes already in the pipeline. Or just shrug it off.
"Sheeple" indeed.
WHEN the change'n'tax'n'hope will show up in the stock values for things like reit's is the question.
Just as with the end of the canroy gravy train in Canada, I am staying clear of this area as a general plan right now. This is a great change from my plan last year, where I spent a great deal of time in the high-yield patch.
(ARCC) was the last stock I was holding for yields, and I sold the last of it a while back. Those few stocks I own now that pay dividends were picked for other primary reasons, but I am keeping them on a short leash.
When the Bush tax cuts expire, the upheaval will catch many investors leaning the wrong way.
What I expect will happen in general will be a combination of strategies, including special dividends/distributions, and a lot of merger and acquisition action similar to the passion spiel with (ARCC), (ALD) and (PSEC). As companies who own pieces of one another try to sort out the problems and issues, food fights are liable to become common. Resorting to trading options as part of the battling would be predictable, imo.
Settle Dt. Qty. Short__ %Chg_ Avg Vol_ Days2Cvr_ %Short
12/31/09 12831203_ -5.06_ 1807212_____ 7.10__ 16.13
01/15/10 12496590 _ -2.61_ 2213605_____ 5.65__ 15.72
01/29/10 13161425 __5.32_ 1467340______8.97__ 16.55
Without knowing what's happened in the first 2 weeks of February, I can't really say if the action I've seen really is short covering, but seeing the short interest showing recent increases through January while the days to cover also increases makes me think I've judged some of the action correctly. With almost nine days to cover, as of last month end, and share price seeming to have bottomed and trying to rise of natural causes, and the recent conference presentation mentioning significant mileposts in Q1 and Q2 coming, I suspect there is some pressure to start covering.
Do note that daily volume has been genrally increasing the lat few days (due to shorts covering?) and this can reduce the pressure to cover, and threfore upward porice pressure attributable to shorts.
HardToLove
Merial, a world-leading animal health company, has gained full-licensure from the U.S. Department of Agriculture for ONCEPT(TM) Canine Melanoma Vaccine, DNA. ONCEPT is a breakthrough vaccine indicated for aiding in extending survival of dogs with stage II or stage III oral canine melanoma, a common yet deadly form of cancer in dogs.
ONCEPT is the first and only USDA-approved, therapeutic vaccine for the treatment of cancer - in either animals or humans.
Traditionally, dogs with stage II or stage III malignant melanoma survive less than five to six months when treated with surgery alone.(1) Clinical studies of ONCEPT demonstrated significantly longer life spans even in dogs with stage II or stage III of oral melanoma. In fact, median survival time of dogs treated with
ONCEPT could not be determined because more than 50 percent of the treated dogs were still living melanoma-free at the conclusion of the study or died of unrelated illness.(2)
Canine oral melanoma is a common type of cancer in dogs and is the most common malignant tumor of the dog's mouth. It can also be seen in the nail and footpad.(3) Canine melanoma may be seen in any breed and is a highly aggressive cancer that frequently spreads throughout the body, including the lymph nodes,
liver, lungs and kidneys.(4) To date, the most common treatments for this form of cancer have been radiation and surgery to establish local tumor control. Canine oral melanoma, however, has a high propensity to metastasize to other parts of the body and is often resistant to chemotherapy.(2,3) "Canine melanoma spreads readily, and, unfortunately, existing treatments have not succeeded in controlling the disease," said Dr. Bob Menardi, a veterinarian and spokesperson for Merial. "ONCEPT is a new adjunct treatment option for dogs that have been diagnosed with this often fatal disease."
The vaccine was developed through a partnership between Merial and Memorial Sloan-Kettering Cancer Center. While Memorial Sloan-Kettering was testing a human melanoma vaccine, they received an inquiry from Dr. Philip Bergman - who at the time was with Animal Medical Center, and currently with Brightheart Veterinary Center - seeking novel treatments for canine melanoma. The discussions resulted in clinical trials of the Memorial Sloan-Kettering melanoma vaccine, and subsequent parallel trials by Dr. Bergman and Memorial Sloan-Kettering refined the dosage and protocol to the current therapeutic regimen for dogs. Dr. Bergman completed the initial clinical work on ONCEPT at Animal Medical Center in New York.
"We're very excited about continuing research into this vaccine to explore the potential implications it has for humans. We hope this will result in improved cancer treatment for all," explained Jedd D. Wolchok, MD, PhD, a medical oncologist who specializes in immunotherapy on the Melanoma and Sarcoma Service at Memorial Sloan-Kettering and also Associate Director of the Ludwig Center for Cancer Immunotherapy.
The USDA issued a conditional U.S. Veterinary Biological Product License for ONCEPT in 2007. During the period of conditional licensure, ONCEPT was available to veterinary oncologists as Merial conducted additional research to further support the safety and efficacy of the vaccine.
The results of that research led to the full licensure of ONCEPT. Merial obtained licensing rights from Memorial Sloan-Kettering and Dr. Philip Bergman, and, using their access to and experience with DNA vaccine technology licensed from Vical Incorporated (VICL), completed the industrialization and regulatory requirements for full licensure. The vaccine will be administered via a Canine Transdermal Device, which delivers the vaccine without the use of a needle.(5) The device was developed in conjunction with Bioject, Inc., a Portland-based drug delivery company (BJCT).
"The Canine Transdermal Device makes administration of the vaccine easy and quick for oncologists and their patients, leaving one less worry for dog owners dealing with their pet's cancer treatment" said Dr. Richard Stout, executive vice president and chief medical officer of Bioject. "We are proud to work with Merial
in bringing this breakthrough product to market."
"The approval of ONCEPT is a milestone in the cancer vaccine field and a significant advancement for our DNA delivery technology platform," said Vijay B. Samant, Vical's President and Chief Executive Officer. "Therapeutic vaccines -- the holy grail of vaccinology -- are delivered after disease onset to impede disease progress for the patient's benefit. We believe this achievement is a major step toward the initial approvals of therapeutic vaccines for humans."
ONCEPT is available for use by specialists practicing veterinary oncology, so pet owners will want to ask their veterinarians about how best to access this treatment option.
Merial is a world-leading, innovation-driven animal health company, providing a comprehensive range of products to enhance the health, well-being and performance of a wide range of animals. Merial employs approximately 5,700 people and operates in more than 150 countries worldwide. Its 2009 sales were $2.6 billion. Merial is the Animal Health subsidiary of sanofi-aventis. For more information, please see www.merial.com.
Bioject Medical Technologies Inc., based in Portland, Oregon, is an innovative developer and manufacturer of needle-free injection therapy systems (NFITS). NFITS provide an empowering technology and work by forcing medication at high speed through a tiny orifice held against the skin. This creates a fine stream of
high-pressure fluid penetrating the skin and depositing medication in the tissue beneath. The Company is focused on developing mutually beneficial agreements with leading pharmaceutical, biotechnology, and veterinary companies. For more information about Bioject, visit www.bioject.com.
Vical researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases. Potential applications of the company's DNA delivery technology include DNA vaccines for infectious diseases or cancer, in which the expressed protein is an immunogen; cancer immunotherapeutics, in which the expressed protein is an immune system stimulant; and cardiovascular therapies, in which the expressed protein is an angiogenic growth factor. Additional information on Vical is available at www.vical.com.
HardToLove
finance.yahoo.com/mark...
Previously, Mr. Erck served as President and Chief Executive Officer of Iomai Corporation, leading the company through an initial public offering and a merger with Intercell, an Austrian vaccine company, and through the development of a late-stage infectious disease product candidate. Prior to Iomai, Mr. Erck served as President and Chief Executive Officer of Procept, a publicly traded immunology company; as Vice President of Corporate Development at Integrated Genetics (now Genzyme), and in management positions at Baxter International. Mr. Erck currently sits on the Board of Directors of BioCryst, MacCyte, MdBio Foundation and Novavax.
"We are very pleased to announce the appointment of Stan to the position of Executive Chairman of the Board," stated Gary C. Evans, Lead Director of Novavax. "Stan's business experience in guiding successful infectious disease and vaccine based biotech companies should prove invaluable to Novavax as we advance our VLP pipeline into late-stage development and commercialization."
finance.yahoo.com/news...
What caught my eye with this article was its title, "CelSci R&D Costs Triple".
Then it proves, quoting from the financial statement that R&D costs from the year earlier were $1.4million, vs $2.8million...
Delete "triple" and insert "double". This sort of thing annoys me...
Or is this one of those nutball times when the idea is that we spent $1 last year, and $2 this year, so our costs "tripled", with the idiotic underlying (but unstated) assumption that R&D costs occur only "once"?
I'm buy some today.
" It is the first flu virus that can infect humans throughout all four seasons. As a flu virus it undergoes rapid mutations. As such, similar to the normal seasonal flu, we are likely to see H1N1 reappear in a mutated form. Our greatest fear is that it might pick up pieces of genetic information from the more deadly Avian flu or the Spanish flu and become an easy to transmit life threatening virus. To address this possibility, CEL-SCI scientists have included in the LEAPS-H1N1 investigational treatment non-changing parts of the H1N1 virus, as well as non-changing parts of the Avian flu and Spanish flu viruses. We will continue with the development of this investigational treatment because we expect it to become increasingly important in the future".
This asserts that H1N1 is likely to hang around for a long time, likely to mutate and might carry the ill-effects from more virulent virus.
That portends good prospects for the success of VICL and NVAX along with CVM since if the above is true the opportunity to apply the efforts for H1N1 and related has not really been missed.
HardToLove
Also bought (SHAW), (DNN) and (XRX), added 100 more shares of (SYMS).
Now I have (VICL) and (CVM) for pharma, though I will be taking profits on CVM. I have a stop set at .70 on CVM.
PDF: www.novavax.com/downlo...
Not a lot of meat in the release though.
HardToLove
(CVM) is trying to turn me into a daytrader.
PDF: www.novavax.com/downlo...
Summary: • Positive Clinical Results from Pivotal Study of H1N1 Virus-Like Particle (VLP) Pandemic Influenza Vaccine in Mexico
• Immunogenicity responses at all dose levels meet U.S. and European regulatory authorities recommended criteria for seroconversion and seroprotection
• More than fifty percent of the volunteers already enrolled in Stage B of study
NVAX: NOVAVAX, Inc. Receives NASDAQ Non-Compliance Letter
PDF: www.novavax.com/downlo...
The meat of it: "received a notice of deficiency, as expected, from the NASDAQ Stock Market (NASDAQ) listing qualifications department. As a result of the election of Stanley C. Erck as the Executive Chairman Novavax is no longer in compliance with the NASDAQ requirement set forth in Listing Rule 5605(b)(1), which requires that the company’s Board of Directors be comprised of a majority of independent directors.
Novavax has 45 days to submit a plan to NASDAQ to regain compliance. The notification has no immediate effect on the listing of Novavax’s common stock on The NASDAQ Global Market. The Company's common stock continues to trade on The NASDAQ Global Market under the symbol “NVAX”.
HardToLove
(February 17) Chile Buys 2 Million Doses of Swine-Flu Vaccine
The health ministry of Chile announced it has purchased 2 million doses of H1N1 flu vaccine in anticipation of the start of the Southern Hemisphere's flu season, adding to 500,000 the government already has on hand.
In 2009, swine flu affected 368,129 people in Chile, resulting in 150 deaths, the Health Ministry said in a report.
www.laht.com/article.a...
(VICL) even with the board (a win for this environment).
(CVM) flat, hovering around .64.
www.foxnews.com/story/...
Very positive results from (VICL) Phase 1 trials.
ir.vical.com/releasede...
HardToLove
finance.yahoo.com/mark...
(February 23, 2010) Swine flu wanes, but experts say pandemic strain could re-emerge. By David Brown, Washington Post Staff Writer
…
The growth and maintenance of a disease outbreak is a matter of simple arithmetic. If each person carrying a microbe passes it on to more than one person, the epidemic will spread. If each person passes it, on average, to less than one person -- which means that many people don't transmit it to anyone -- then the epidemic will eventually burn out.
How many people the average infected person infects is called the basic reproductive number, or R0 (pronounced "R naught"). It is a crucial feature of each microbe's personality. Some microbes are simply more transmissible than others; they have a higher R0.
Measles, which is probably mankind's most contagious infection, has an R0 of about 18. Polio's number is about 6; severe acute respiratory syndrome (SARS) about 5. For seasonal flu strains, the R0 is about 1.2, and for pandemic strains it is rarely higher than 2. For the novel H1N1 strain (also known as swine flu), it's about 1.6. What this low R0 means is that flu outbreaks are always teetering on the verge of having their myriad chains of transmission broken by people who get infected but don't pass the virus to anyone else.
Flu viruses typically spread quickly among children, who gather in school and then pass the virus on to the rest of the population. The brief first wave last spring was most evident in schools, particularly in New York. The virus spread during the summer in places where children congregated, specifically camps. The second wave took off with the nationwide resumption of the school year in September.
"The main determinant of decline is vacation period, and the main determinant for the rise again is the aggregation of people for school terms," said Roy Anderson, a professor of infectious disease epidemiology at University College London.
One consequence of this is that when a lot of children get infected, recover and become immune, the entire epidemic slows down. "With this virus, once about half the children are infected . . . then you really can't sustain transmission unless the infectivity goes up for some reason," said Ira Longini, a disease modeller at the University of Washington.
That's apparently what happened last fall and in the Asian flu of 1957, its eerily similar predecessor. Visits to doctors' offices for flu peaked in this pandemic in the week ending Oct. 24. In 1957, school absenteeism peaked in the last two weeks in October, depending on the city. (In both epidemics, the peaks occurred before there was any appreciable use of vaccine.)
What's next?
So why did the virus start to ebb so early, and does that say anything about the likelihood of a third wave?
In 1957, the epidemic may have simply have run out of children. A study of one of the first places hit by the 1957 virus -- Tangipahoa Parish, in Louisiana -- found that 60 percent of schoolchildren were infected in that fall wave. What fraction of schoolchildren are now immune to the H1N1 virus -- either because they've had it, or have gotten the swine flu vaccine -- isn't known. But CDC is trying to find out.
The Asian flu virus came back in February 1958, ultimately killing about 20,000 people (compared with 40,000 in the fall). Most of the deaths occurred among old people, who were spared in the fall for mysterious reasons -- possibly because they had little contact with schoolchildren. Epidemiologists believe today's elderly may be partly immune to the H1N1 virus because of exposure to a related virus that circulated more than 40 years ago. If so, an Asian-flu-like third wave is less likely.
What does seem clear is that environmental conditions for a flu outbreak are better now than they were last October.
A study published in December in the journal Public Library of Science Currents provided real-world support for numerous lab experiments showing that flu virus survives best in dry air.
A team of virologists and climate researchers, led by Jeffrey Shaman of Oregon State University, showed that over a period of 31 years seasonal flu outbreaks in the United States consistently started about three weeks after a marked decline in the humidity of the air. They used this observation to predict the timing of outbreaks in five states with different climates (Arizona, Florida, Illinois, New York and Washington), and the predictions were accurate.
The message is clear: When the air is dry, the virus spreads. Typically, winter air -- both outdoors and in -- is the driest of all seasons. The air is drier now than it was last fall, so the H1N1 virus should be spreading better now than it did in October. But it isn't.
Of course, there may be other reasons for that, including the need for influenza virus to compete with other microbes for human noses and throats. When a person is infected with one respiratory virus (such as rhinovirus, which causes colds), the chance of catching a different virus (such as flu) declines greatly. Part of the reason is that the first infection provokes what's called "innate immunity" -- a flood of interferon and other cellular hormones that defend the body in a general way without specifically targeting the invader. That protection can last weeks, breaking chains of transmission and slowing a flu epidemic.
A similar form of interference occurs between strains of flu, which is one of the reasons there's been almost no "seasonal flu" in recent months. The strains circulating last season and still occasionally found this season -- H3N2, other forms of H1N1 and influenza B -- have all been out competed by the upstart H1N1.
In fact, even if there isn't a third wave, the new H1N1 may well spell the end of one or more of the families of flu virus that have been circulating for decades. That's what's happened in previous pandemics, at least.
The H1N1 family arrived in 1918 with the Spanish flu. In the 1957 pandemic, the new virus was in the HN2 family; it drove all H1N1 strains to extinction. In 1968, the new virus was an H3N2. It spelled the end of the H2N2 family, which disappeared. H1N1 returned in 1977, apparently the result of an accidental release from a laboratory in Russia or China.
Like all pandemic strains, the novel H1N1 virus (or an immediate descendant of it) will eventually infect -- but not necessarily sicken -- nearly everybody on Earth who isn't already immune to it through vaccination. It may take years. It could happen by unpredictable waves or slow percolation. But it is virtually inevitable.
"We're going to have this virus for many decades to come," said Longini, the University of Washington epidemic modeller. "And we don't know what it's going to do next."
tinyurl.com/yaxdfyd
Seriously, that article makes me think that being in these two companies long-term is a good move.
Thanks for that post.
HardToLove
VICL I took profits on a while back, then backfilled. I truly like the stock.
CVM is just a way to make money, so far. It is incredibly volatile.
HardToLove
Short down 5.02% to 12,500,901 but still 7.76 days to cover due to reduced average daily trading volume, 1,610,292.
Short interest has been hanging in at the 12.5-13.5 million since mid-October last year while overall daily trade volume has trended down.
HardToLove
Innov * P monovalent influenza A (H1N1) 2009 PPV vaccine is a virus-like particles (PPV) inactivated indicated for active immunization of adults 18 to 64 years of age against influenza disease caused by pandemic virus (H1N1) 2009.
I sent an email to M. E. Garza who is highly knowledgeable.... I will let you know if I get a reply.
Holding some CVM and VICL, too.
I see today as one of those odd dollar up, euro and pound down, American equities up, days.
Watch oil trades. Something is up in OPEC... I have seen these things affect pharma and chemical stocks in the past... Don't ask me to show any science behind this linkage, its one of those mysterious connections that I'm pretty sure exist, but I can't say precisely why...
Since last Oct, short *interest* has stayed 12.5-13.5 million.
HardToLove
HardToLove
This deal with Avimex is certainly interesting. Looks like Avimex is expanding from animal-only drugs to human vaccines, and we're front & center with that initiative for them. Avimex already has established customers around the world, so once we get official approval to start selling, it's off to the races!
HardToLove
Looks like NVAX has leveled out and is now going sideways. We'll see where it goes over the next few weeks.
Health authorities reported yesterday that they have closed the first private school in the capital due to H1N1, now that the illness has caused an absenteeism rate of 39 percent, confirming that in recent days five pupils are carrying the virus. Dowal School was closed temporarily after reporting a pupil absenteeism rate of 39 percent. This triggered alarms in the public health system, since no schools in Tegucigalpa have been closed for this reason in the past six months.
crofsblogs.typepad.com.../
Looks like the down-trend in NVAX is finally over. Some decent buying activity, little selling the past few days.
Wait until the election cycle cranks up.
The activity levels will spike.
Pandemic Hybrid Of Bird And Human Seasonal Flu Possible Say Scientists
An international team of scientists has created a highly pathogenic laboratory hybrid of the H5N1 bird flu and human seasonal flu viruses by swapping just one gene, and propose that a similar genetic interaction could happen in nature between the current pandemic H1N1 swine flu and H5N1 avian flu strains, highlighting the importance of continued surveillance.
Based on reported statistics, once it infects humans, the H5N1 bird flu virus kills humans at a much higher rate than the H1N1 swine flu virus circulating amongst us in the current global pandemic. According to the World Health Organization (WHO), as of 21 December 2009, H5N1 had spread worldwide among bird populations and caused 447 confirmed human cases and 263 deaths.
When two different virus strains infect the same host, they often exchange genes, a process known as reassortment. A significant number of experts are concerned that as H5N1 spreads more widely and infects more people, it will come across more hosts who are also carrying human seasonal flu viruses. This increases the likelihood of a new strain emerging that has the severity of the bird flu virus and the infection rate of the swine flu virus, leading to a new global pandemic with much deadlier consequences than the one we are experiencing at the moment.
H5N1 virus has never acquired the ability to transmit among humans, which is why we haven't had a pandemic. The worry is that the pandemic H1N1 virus may provide that nature in the background of this highly pathogenic H5N1 virus
www.medicalnewstoday.c...
Enrollment in largest clinical study in Novavax's history of over 4,500 subjects completed in less than 5 months
ROCKVILLE, Md., March 8, 2010 /PRNewswire via COMTEX/ -- Novavax, Inc. (NVAX)
announced today that the enrollment of over 3,500 subjects in Mexico has been completed in Stage B of its pivotal 2009 H1N1 virus-like-particle (VLP) pandemic influenza vaccine study. With the 1,000 subjects already enrolled in Stage A of
the trial, the enrollment in this pivotal trial is now complete with over 4,500 subjects.
In this Stage B of Novavax's pivotal study of H1N1 influenza vaccine candidate, a cohort of 3,500 healthy volunteers aged 18 to 64 years old were enrolled. 2,500 of the subjects received a 15 mcg single dose of Novavax's unadjuvanted 2009 H1N1 VLP pandemic influenza vaccine candidate while 1,000 of the subjects received placebo. The 15 mcg single dose regimen was recommended by the Data and Safety Monitoring Board (DSMB) after reviewing the results of safety and immunogenicity data from a subset of the 1,000 subjects in Stage A of this trial. These data were recently presented at a meeting sponsored by the World Health Organization in Geneva (presentation available on www.novavax.com). The purpose of the Stage B portion of the study was to evaluate safety. Favorable data from Stage B of this study will position Novavax for possible registration of the 2009 H1N1
VLP pandemic influenza vaccine candidate in Mexico.
"Novavax has now completed enrollment of the largest clinical trial in the Company's history," said Dr. Rahul Singhvi, President and Chief Executive Officer of Novavax. "This was an ambitious program from the start and we now have realized a remarkable milestone in less than five months. To conduct a clinical trial of this magnitude is a significant undertaking in any circumstance. For a Company of our size to achieve this goal under such time pressure is testament to the dedication of our employees and collaborators in Mexico. I am confident that the quality of the data from this part of the study together with the encouraging results to date from Stage A of the trial will enable Novavax to move closer to ultimate product registration."
HardToLove
www.theflyonthewall.co...
This doesn't look like a typical investment-bank type of meeting. Me thinks something's a-brewing here! There isn't a PR about this, and thefly seems to be pretty good about getting the scoop on things like this.
HardToLove
I think this meeting with Global Hunter is going to prove to be a very significant event for nvax, though we won't see any immediate result/action directly from it.
Chen Qi
India is 'most likely' to administer imported swine flu vaccine to the high risk groups from next week, a senior health ministry official said Wednesday. "Most likely, we will start the vaccination next week," V.M. Katoch, secretary (Health Research) in ministry of health and family welfare, said.
www.dowell-netherlands...
(March 10) CEL-SCI Corp receives payment from marketing partner (CVM): Co has received a $125,000 payment from Byron Biopharma under its licensing agreement where CEL-SCI granted Byron an exclusive license to market and distribute the Company's cancer drug Multikine in the Republic of South Africa. Under the agreement, Byron will also be responsible for registering the product in the Territory. Once Multikine has been approved for sale, CEL-SCI will be responsible for manufacturing the product, while Byron will be responsible for sales in the Territory. Revenues will be split 50/50 between CEL-SCI and Byron.
finance.yahoo.com/mark...
We'll have to wait and see if a trend has started. Last several days have tended towards the positive side.
Trend started @ 11:10 EST and peaked to $2.58 before dropping back. Good volume and pretty much straight up.
HardToLove
Dr. Rahul Singhvi, President and Chief Executive Officer of Novavax will be presenting at the 22nd Annual ROTH OC Growth Stock Conference. The presentation will take place on March 15, 2010 at 8:30 am pacific time at the Ritz Carlton, Laguna Niguel, California. Dr. Singhvi will provide an overview of the company’s business strategy, research and development progress and upcoming milestones. A link to the
live presentation can be accessed via the company website at novavax.com under the Investors tab. An archive of the presentation will be available one hour after the event on the
Novavax website for 90 days.
HardToLove
Over in China, a big investors presentation just occurred. Guess what! Many stocks that were to be presented surged before the conference, and then dropped back afterwards.
For example, check out one of my favorite Chinese stocks, Wonder Automotive Technology (WATG). Look on the chart what happened before the conference, and what has happened since. I peeled off a few shares that were toppy on late Monday, then bought the same amount of shares back today for ~ 50 cents per share less. A minimal gain, on a minimized experiment. But it worked.
Same could be true for NVAX with this upcoming conference.
I've also been pondering another possibility. In the past, options expiration week was a strong short-covering period. Some months back I noticed several stocks I follow seemed to have rises the week before that and then sort of just flop around a bit during options expiration week. My thought is maybe the shorts have decided that better results are obtained if they start covering earlier since everyone knows about options expiration week now.
I haven't looked to see if this is true and/or a pattern yet, but I'm keeping an eye on it to see if some further investigation is warranted.
HardToLove
Novavax reported a net loss of $14 million, or $0.15 per share, for the fourth quarter of 2009 compared to a net loss of $11.1 million, or $0.16 per share, in the fourth quarter of 2008. For 2009, the company reported a net loss of $38.4 million, or $0.45 per share, compared to a net loss of $36 million, or $0.53 per share, for 2008. The primary reason for the increased loss in the comparative fourth quarter and year-over-year results are the number and size of the clinical
trials that were performed in 2009, compared to 2008.
At December 31, 2009, Novavax had cash, cash equivalents and short-term investments of $43 million compared to $33.9 million at December 31, 2008. Working capital increased from $7.4 million in 2008 to $36.5 million in 2009.
HTL: There's a lot more detail and list of expected 2010 activities, but too long to list here. Results not yet on co. web site. SEC filings
www.sec.gov/cgi-bin/br...
NVAX:
Novavax's management will host its quarterly conference call at 10:00 a.m. Eastern time today. The live conference call will be accessible via Novavax's website at www.novavax.com under Investor/Events or by telephone at 1 (866) 804-3550 (U.S. or Canada) or 1 (703) 639-1330 (International). An archive of the conference call will be available on Novavax's website approximately one hour after the event for 90 days and a replay of the conference call will also be available by telephone beginning March 12, 2010 at 1:00 pm through March 14, 2010 at 11:59 pm. To access the replay, dial 1 (888) 266-2081 and enter pass code 1412843.
HardToLove
HardToLove
tinyurl.com/yhgmdnn
HardToLove
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StockTalks
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The final Markit U.S. manufacturing purchasing managers index reached 54.0 in December... woo woo
Jan 2, 2013
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Good potential for a market whipsaw given the high for the cliff vote combined with unknowns of thePMI and ISM scheduled for this morning.
Jan 2, 2013
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Quadruple Witching occurs on Friday Dec 21.
Dec 17, 2012
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