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Swine Flu News Concentrator (March 13 - April 8) 103 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: 4/2/10
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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
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Last Swine Flu News Concentrator Links:
Swine Flu News Concentrator (February 12 - March 13)
tinyurl.com/ykba7dl
Swine Flu News Concentrator January 25 to February 12
http://preview.tinyurl.com/yjccho4
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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
tinyurl.com/ygtl4ls
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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)
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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...
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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)
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This post has 103 comments:
Markjseventy is a member of shortsqueeze.com and authored a good Insta explaining/defining shortsqueeze's indicators. In the comment section I asked him to bring up NVAX's squeeze. Scroll down to see his interpretation and the latest rankings.
seekingalpha.com/insta...
(VICL) has been strong, it is becoming a solid little pharma anchor in my portfolio, while (CVM) is still going nowhere.
(NVAX) is looking stronger to me. I'm up there, and holding pat.
Short 12,263,808, down 1.9%, avererage daily volume of 1,060,493 means it now takes 11.56 days to cover, the highest since 3/31/2009 period end. Volume Weighted Average Price (VWAP), using daily mean price, was $2.34.
HardToLove
SEC filings here - I'm just starting to look at them now.
www.sec.gov/Archives/e...
HardToLove
"Each share of common stock includes a right to purchase Series D Junior Participating Preferred Stock attached to the common stock."
Two prospectus: a normal one and "a sales agreement prospectus covering the offering, issuance and sale of our common stock that may be issued and sold under a sales agreement with McNicoll, Lewis & Vlak LLC."
Here
www.sec.gov/Archives/e...
the second prospectus included indicates 25MM shares. Quite dilutive.
"This prospectus relates to the sale of up to $50,000,000 in gross proceeds of our common stock pursuant to the sales agreements. Our board has authorized 25,000,000 shares of common stock to be sold pursuant to this prospectus."
"... we will pay our sales agent a commission equal to 2% of the gross proceeds of the sales price per share."
"Based on the closing price of our common stock on March 11, 2010, because we are limited to the sale of common stock with gross proceeds aggregating $50,000,000, the maximum number of shares we could sell is 20,161,290. If 20,161,290 shares of common stock were sold at the March 11, 2010 closing sales price, we would receive $50,000,000 in gross proceeds, or $49,000,000 in aggregate net proceeds assuming the sales agent fee is paid as described above. The actual proceeds to us will vary".
"The net proceeds of this offering will be added to our general funds and used for pre-clinical studies and clinical trials of our VLP-based vaccines, internal research and development programs, working capital, capital expenditures and other general corporate purposes as further described in this prospectus under the heading “Use of Proceeds.”".
HardToLove
Dilution means NVAX should be available at a lower price soon.
The Investigational New Drug (IND) application describing the trial design had been allowed by the U.S. Food and Drug Administration (FDA) in 2009, so the new funding clears the path for the trial to begin.
"The 2009 outbreaks of H1N1 pandemic influenza provided an excellent opportunity for Vical to demonstrate the speed of our vaccine development approach, particularly in the crucial early weeks," said Vijay B. Samant, Vical's President and Chief Executive Officer. "Our collaborators within the U.S. Navy are focused on developing a more responsive vaccine platform to provide rapid protection for military personnel against future emerging disease threats. The Navy funding of a Phase 1 trial allows us to build on the success of our H5N1 vaccine, expand the safety and immunogenicity database for Vaxfectin(R)-formulated vaccines in humans, and open the door to broader collaborations with the U.S. government."
As previously announced, Vical was the first company to produce a vaccine against the A/H1N1 influenza virus after the initial reports of widespread outbreaks in Mexico, and the first to announce robust immunogenicity results from animal testing in two species. The company has opted to advance the H1 DNA vaccine, formulated with Vical's patented Vaxfectin(R) adjuvant, only with continued government funding.
HardToLove
Parenteral Drugs India Ltd (PDIL) today said it has entered into an exclusive distribution deal with Chinese Sinovac Biotech Company for purchase and supply of HIN1 influenza vaccine in the Indian market.
Headquartered in Beijing, the company is a leading vaccine player in China and the first in world to receive approval for H1N1 influenza vaccine, a statement said.
news.webindia123.com/n...
(VICL) was a little sleepy today, but (CVM) regained some ground, and remains slightly above where I bought in most recently (though for no apparent reason).
I am tracking a dozen pharma stocks, but none that I really want to jump on right at the moment.
In the long run, I think NVAX should have the advantage because they are using a faster development and manufacturing method (virus like particles as opposed to the old chicken method). So once they get their first product going, they should have a faster ramp-up process.
VICL is number three on my to buy list when I re-enter the market. I don't understand CVM at all... But I am keeping them on my radar screen.
Last year I was doing some three day after secondary trading that plum worked really well; should have done this trading idea with SVA.
SVA is on my radar as being a super stock to own. Just want to hear some more "clamoring."
They appear to now be on rails with their plans, including adding 5% or so (probably done all at once, though they love incremental steps in these things) to the yuan.
My (CTEL) has worked out remarkably well (and pays me over 7% yield), though I will start taking profits on it shortly (I'm waiting for the currency boot to drop).
(SVA) may well be my next Chinese adventure, and one which I need to get into fairly quickly (I believe the yuan up-peg will occur over the next quarter).
Its a race as to whether they hit their low plateau before the currency revaluation.
I'm thinking they are selling at half their 52 week high right now, but might drop another 20%, so I'm holding off for a while to observe.
o announces positive results from the entire 1,000 subject Stage A of its two-stage pivotal study evaluating the safety and immunogenicity of Novavax's unadjuvanted 2009 A/H1N1 virus-like particle pandemic influenza vaccine. The data showed that safety and immunogenicity of the vaccine were consistent with preliminary results disclosed earlier from the first 500 volunteers of Stage A where the vaccine was found to be well tolerated and immunogenic at all three dose levels tested. Novavax is conducting this study in collaboration with Avimex Laboratories of Mexico to support registration of the vaccine in Mexico and potentially other countries.
-- Independent Data Safety Monitoring Board (DSMB) concludes that Novavax's
2009 H1N1 VLP pandemic influenza vaccine is well-tolerated and induces robust
immune responses with a single injection at all dose levels tested
-- Stage B enrollment completed with over 3,500 volunteers in the trial
HardToLove
Novavax Inc. (NVAX) announced what it called positive results from Stage A of its two-stage study evaluating the safety and effectiveness of a pandemic influenza vaccine.
Shares recently rose 5.6% premarket to $2.47. The stock has more than tripled in the past 52 weeks.
The data showed that safety and immunogenicity, or ability to invoke an immune response, were consistent among the entire 1,000-person study population with preliminary results previously disclosed from the first 500 volunteers of Stage A, where the vaccine was found to be well-tolerated and immunogenic at all three dose levels tested.
Novavax is conducting this study in collaboration with Avimex Laboratories of Mexico to support registration of the unadjuvanted 2009 A/H1N1 virus-like particle pandemic influenza vaccine in Mexico and potentially other countries. Virus-like particles mimic the external structure of viruses but lack the live
genetic material that causes viral replication and infection.
The study is being conducted at the Mexican Institute of Social Security, Latin America's largest medical and research center. Novavax President and Chief Executive Rahul Singhvi said the company has applied for approval in Mexico. Stage B of the study has completed the enrollment of 3,500 volunteers.
Novavax raised $56 million in capital last year to help fund its drug-development efforts. The biotechnology company's focus is vaccine creation using its its virus-like particle technology.
HardToLove
---
This could be interesting going forward.
HardToLove
Anyone know when we might expect to see the results from the 3,500 patient study? Sure seemed to take a long time to get the full 1,000 patient results out, but am hoping this Stage B result reporting moves quickly.
--
Stage B of the study has completed the enrollment of 3,500 volunteers.
5x volume in a half day? Looks like the shorts (will have to, have had to?) make a decision.
HardToLove
We had a gap open and I expect to see NVAX pull back to try to close the gap. When the initial sentiment kick wears off, it may be that it'll do another slow down move to some new consolidation point. With the positive outlook provided by this mornings news, the new low points should be higher than in the past.
What I can't gauge: possible upside moves from folks getting the news late. If we have a lot of new entries continuing for several days, there may be no move back to fill the gap. Or it may partially fill, around $2.45?
A critical factor will be seen tomorrow. If an isolated island is formed (opens gap down and doesn't fill that gap), it';s a very bearish sign. I'd rather see it open in range and then as it trends lower over time with normal volumes I'll feel a bullish trend will be developing shortly.
If the positive news is picked up on the chat boards, SA articles, etc. then we should see a strong up continue.
I'll do a more in-depth this evening and if I see anything to add to my thoughts, I'll post. Maybe I can see what Fibonacci shows - if I'm to learn that, I have to start using it too.
Heh! Nothing like a wishy-washy CMA evaluation, eh?
HardToLove
One thing I don't know how to assess is the effect on later stage reporting, as we've seen today, on future price action. I would think that the further along the phases we get, the stronger the effect on price would be.
I'm also hoping we hear some news from their India partner soon - that would give a big boost. For now though, I think the Mexico progress will be most likely and, *maybe*, one of the southern hemisphere countries might place an order when the Mexico approval comes through.
Probably a long shot though and User (I think it was him?) pointed out that the southern countries tend to buy lower volumes of vaccines.
HardToLove
Human nature, I guess.
Today's range $2.55-$2.72 and close $2.60 w/excellent volume, 6.715MM trades done.
HardToLove
Allende is no longer with NVAX - she's working at Baxter now. We heard that she left the company a month ago, but no PR/filing was done even though she was an officer of the company. Allende was instrumental in the Mexico testing.
Not sure what to make of this, but the timing is interesting to say the least. Apparently no non-compete clause in her agreement. Interesting, interesting.
Info below from Allende's Linked In page:
Maria Allende
Current Medical Director at Baxter BioScience
Past Executive Director, Clinical Research and Immunology at Novavax
Director, Clinical Development at MedImmune Vaccines (purchased by Astra-Zeneca in 2007)
Medical Officer at Vaccines Clinical Research Branch, NIAID, NIH
Medical Officer at DMID, NIAID, NIH
Associate Director, Biologics, Clinical Research at Merck and Co., Inc.
Before this latest twist, I thought Merck would be the one to step up, but now I believe Baxter will be doing so instead. Allende ran the Mexico trial program well and presented the data to the WHO, and now she's working at Baxter without so much as an official word from NVAX on her departure. She might be considered a "shared resource" between the two companies if/when they enter into a partnership.
Thoughts/comments?
I like your thinking though. Thank you for taking the time and sharing with all of us.
HardToLove
"In contrast to the use of embryonated chicken eggs, Baxter's Vero cell-based manufacturing uses a highly standardized, closed production process13, ensuring freedom from interaction between the vaccine and its environment, and has high purity in the absence of antibiotics.
Another major advantage of the Vero cell line is that it can be grown and infected on microcarrier beads and cultivated in fermenters, allowing large-scale production of vaccines. "
www.baxter.com/press_r...
Prognosis (set myself up for a good "spanking"): with the news yesterday, the CNBC mention last evening and market still trending up, I think we see some more strength today towards the upside. I'll be looking more towards intra-day strength than close, as I expect some profit taking would be a responsible move by many.
I'll be looking for "confirmation" volume - not as high as yesterday, but substantially above the prior 10 day average of 1.75MM/day (keep in mind this is skewed by yesterday's 6.77MM, without that it appears to be 1.56MM with most days well below 1MM). I'll also want to see good volumes on the intra-day moves up, with weaker volume on down moves.
HardToLove
This provides some hope that it will settle out over the next few days in the $2.45 level, at the worst. I wouldn't be surprised to see it come back in the $2.50 range as soon as tomorrow if the good news caused a lot of folks to see this drop as a good entry point.
More likely, I guess, when the market gets over today's latest "earthquake" out of Europe and if it doesn't let the short-term U.S. bond action spook it excessively.
Let's keep our fingers crosses and our resolve firm.
HardToLove.
P.S. Some of the loss is probably due to the general market reaction that started in the mid-afternoon.
(March 26) Rapid Development of Drug-Resistant 2009 H1N1 Influenza Reported in Two Cases
Two people with compromised immune systems who became ill with 2009 H1N1 influenza developed drug-resistant strains of virus after less than two weeks on therapy, report doctors from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. Doctors who treat prolonged influenza infection should be aware that even a short course of antiviral treatment may lead to drug-resistant virus, say the authors, and clinicians should consider this possibility as they develop initial treatment strategies for their patients who have impaired immune function.
Both patients in the new report developed resistance to the key influenza drug oseltamivir (Tamiflu), and one also demonstrated clinical resistance to another antiviral agent, now in experimental testing, intravenous peramivir. This is the first reported case of clinically significant peramivir-resistant 2009 H1N1 illness. The report is scheduled to appear in print on May 1 in Clinical Infectious Diseases and is now online.
www3.niaid.nih.gov/new...
phx.corporate-ir.net/E...
Novartis Vaccines produces vaccines for seasonal and pandemic flu using two of the most
advanced technologies that are currently available for the production of vaccines for influenza:
1) traditional technology based on incubation in eggs and 2) technology based on cell culture.
Both technologies are allowed to be used with the patented adjuvant technology.
Thetechnology to be transferred to ROVI would be selected after a deep analysis of reliability and
costs in order to achieve the main aims of minimizing the risk of the project and complying with
the established schedule.
... released the final results from a Phase II clinical trial evaluating Novavax's trivalent seasonal influenza Virus-like particle (VLP) vaccine candidate in healthy adults. The study enrolled healthy volunteers 18 to 49 years in age who were immunized with a single injection of Novavax's trivalent seasonal influenza VLP vaccine matched to the influenza strains recommended for the 2008-2009 influenza vaccine. Preliminary data from this trial were reported in 2009.
The complete analysis included 232 volunteers in total; with 49 receiving placebo, 83 given Novavax's trivalent seasonal influenza VLP vaccine at 15 mcg/dose, 81 injected with Novavax's trivalent seasonal influenza VLP vaccine at 60 mcg/dose and 19 volunteers receiving an inactivated trivalent influenza vaccine Fluzone(R) (TIV) at 15 mcg/dose. The three strains were H1N1
A/Brisbane/59/2007, H3N2 A/Brisbane/10/2007, and B/Florida /04/2006. The data show that Novavax's trivalent seasonal influenza VLP vaccine induced a robust hemagglutination inhibition (HAI) antibody response against all three strains in the vaccine. Seroconversion rates as defined by the FDA (including lower and
upper 95% Confidence Intervals (CI)) for the 15 mcg group were as follows: 51% (39, 62), 76% (65, 85), and 58% (47, 69) against the H1N1, H3N2, and B strains, respectively. Seroprotection (titer greater than or equal to 1:40) rates for volunteers in the 15 mcg group (with 95% CIs) were 70% (59, 80), 89% (80, 94), and 84% (75, 91) against the H1N1, H3N2, and B strains, respectively.
Preliminary HAI results from this study were presented at the 47th Annual Meeting of the Infectious Diseases Society of America (IDSA) on October 31, 2009 and were described in a company press release dated November 2, 2009. Those interim results were based on evaluation of a total of 190 volunteers, of which 37
received placebo, 69 received trivalent seasonal influenza VLP vaccine at 15 mcg/dose, 67 received trivalent seasonal influenza VLP vaccine at 60 mcg/dose and 17 received TIV. For volunteers in the 15 mcg group, seroconversion rates (greater than or equal to 4-fold rise in titer from baseline) with the accompanying 95% CI were 57% (44, 68), 86% (75, 93), and 62% (50, 74) against the H1N1, H3N2, and B strains, respectively. For volunteers in the 15 mcg group, seroprotection rates (titer greater than or equal to 1:40) with 95% CI were 67% (54, 78), 91% (82, 97), and 84% (73, 92) against the H1N1, H3N2, and B strains, respectively. In the final results reported today, the H3N2 and B strain data in the 15 mcg VLP dose met the FDA seroconversion guidelines of 40 (lower 95% CI) while the H1N1 data fell just short (39.4 versus 40.0). However, the mean seroprotection rate against the H1N1 strain rose slightly from an original 67% to a final 70%.
In addition to the HAI titers, functional antibody against the Neuraminidase enzyme was measured in the sera of immunized subjects using a neuraminidase inhibition assay (NAI). Inhibition of neuraminidase activity may be important in reducing the spread and severity of influenza infection. Novavax tested volunteers for NAI against B/Florida, H3N2/Brisbane and H1N1/Brisbane components of the vaccine before and after immunization. Against the B strain, 59% of the patients receiving the 15 mcg dose of VLP showed a 4-fold or higher rise in NAI titers over pre-immune levels. At the 60 mcg VLP dose, 73% had a 4-fold rise while only one subject (5%) from the TIV population had a 4-fold rise. In the NAI
assay against the H3N2 strain, 50% of the patients immunized with the 15 mcg VLP dose had a 4-fold rise in NAI titers. At the 60 mcg VLP dose, 56% had a 4-fold rise. In the small subset of subjects tested against H1N1 NAI activity (10 placebo and 20 at the 60 mcg VLP dose), the NAI in the VLP treated group increased about 30% over preimmunization levels while the placebo treated group had no increase over pre-immunization levels.
"The data released today show that our VLP influenza vaccine not only induces a robust HAI response but also enhances the NAI response far above that induced by TIV," said Dr. Rahul Singhvi, President and Chief Executive Officer of Novavax. "We will continue measurement of NAI activity in other clinical trials since we
believe that the ability of the VLP vaccine to elicit an NAI response may differentiate our vaccine from others. These NAI results support our position that VLP influenza vaccines have the potential to induce a broad-based immune response that could lead to improved clinical outcomes. We now await comparative immunological and safety data from a larger head to head clinical trial in older adults (>60 years of age) between TIV and our VLP vaccine," said Dr. Singhvi.
About VLPs
Virus-like particles (VLPs) mimic the external structure of viruses but lack the live genetic material that causes viral replication and infection. VLPs can be designed quickly to match individual viral strains and be produced efficiently using portable cell-culture technology. Novavax VLP-based vaccine candidates are produced more rapidly than egg-based vaccines by using proprietary, portable, recombinant cell-culture technology.
HardToLove
HardToLove
April options are very bullish. XD
I added 500 shares this morning.
I'm hoping that, at worst, this will be the consolidation I was thinking might come @ $2.45 or so. If we get that, then we have a base from which to spring higher when the next news comes. Trading just above the 20/50 SMA may give the needed support, especially as the 50 is about to roll slightly up, if we can hold this price.
If just dinks around and works back into the $2.3x range again, I think the shorts won't feel the need and the newer folks waiting for the signal that the run up has at last started will just keep waiting.
We're still below 100/200 SMA and breaking the 100 will be a signal to many when it occurs.
We are pretty much in the neutral with all the usual technicals - MACD, RSI, MFI. A/D still has a nasty negative value, -108.6.
HardToLove
CDC giving warnings for student Spring Breaks, or to the students coming home and further spreading swine flu.
www1.voanews.com/engli...
I assume those bullish future options are institutional investors who are closing out their March portfolios, and now have cash for opening positions in April …. So I am anticipating an up tick in the first few days of April.
At that point, the shorts either need to increase their shorts (raise) to drive the price back down, or they have to fold. 2.4 appears to be a strong support level. That was why I chose to enter at that point.
I now see that NVAX is at 2.57!
(March 26) CDC sees sustained H1N1 activity in Southeast
Lisa Schnirring * Staff Writer
Flu indicators are showing signs of increased and sustained pandemic flu activity in some Southeastern states, though rates remain steady at the national level, the US Centers for Disease Control and Prevention (CDC) said today.
Today's CDC report tracks closely with media reports this week of a rise in flu hospitalizations in Georgia and rising flu-like illnesses in Louisiana and surrounding states. The report of increased activity in the Southeast is also consistent with regional flu activity at college campuses in the Southeast reported by the American College Health Association.
Three of the CDC's 10 regions reported increases in doctors visits for flu-like illnesses, including the one encompassing Southeastern states; the region that includes Iowa, Kansas, Missouri, and Nebraska; and the area that covers Arizona, California, Hawaii, and Nevada. The increases were over regional, not national, baselines. On a national level, the doctor's visit flu barometer stayed below the national baseline.
The CDC is still recommending the pandemic flu vaccine for anyone who is age 6 months or older, and officials strongly urge that people with underlying health conditions, the very young, and people age 65 or older get vaccinated. Vaccine supplies are plentiful and the circulating virus still closely matches the one in the pandemic vaccine.
tinyurl.com/yl9yn2e
Sumthin' up?
Holding (VICL).
I believe (NVAX) still has some time to do the SEC reporting on the "wandering executive" situation. I really can't see the downside, but I'm not sure it represents an upside, either. My gut tells me that there are shadowy forces lurking...
But I am seriously considering getting back into NVAX Monday.
www.washingtonpost.com...
Considering how our government is both gullible and even far more corrupt, I give this a one in three chance of occurring.
Here is one way it could work. NVAX can manufacture their vaccines much cheeper and faster than manufacturers using the egg method. So they enter a market with a lower cost vaccine. Included in the sales contract is a guarentiee for a 25% (or whatever works) discount for replacement product within some negotiated time period. This locks the customer in and NVAX takes the business away from the Big Pharma companies that can't meet the price because they are still using older and more expensive manufacturing methods.
Of course, you also have to consider that the viruses are mutating. Last years flu vaccine may not work for the next years virus. You build that fact into your sales contract. If the customers buys NVAX's product, NVAX provides a 25% discount to replace obsolete product with an up-dated product. A replacement program designed to increase customer loyalty.
Such are the advantages of owning proprietary and innovative technology that lowers production costs while maintaining or improving quality. If you know what you are doing, you can put your competitors into a bad position. This is very likely one of the key reasons Big Pharma is dependent on mergers and acquisitions.
And now with the signing of the agreement with ROVI, everything fits.
XD
Probably risky going in ahead of the conference call, but, I did just buy 500 shares just to keep SAV higher up on my radar.
Holding (VICL).
Thinking over (NVAX)...
www.sfgate.com/cgi-bin...
(April 6) Flu Expert: Southeast Should Be On Guard Because Of Continued H1N1 Flu Spread This Spring
The continued spread of H1N1 influenza virus this spring is cause to pay heed to upper-respiratory maladies such as congestion, runny nose and cough, says David Kimberlin, M.D., a preeminent influenza specialist who co-directs the University of Alabama at Birmingham (UAB) Division of Pediatric Infectious Diseases.
Health officials are carefully monitoring a steady stream in the Southeast of cases of pandemic H1N1 flu, especially in Alabama, Georgia and South Carolina - the three states reporting regional flu activity.
Kimberlin encourages those who have not yet gotten their H1N1 flu shot to do so. The vaccine is widely available throughout the United States at doctors' offices, health departments and pharmacies.
The flu concern in the Southeast is the 2009 H1N1 pandemic strain; primarily it is causing serious illness in adults with underlying health conditions and in young children. Educating the public and emphasizing the need for repeated hand-sanitizer use and disinfectant spray helps control its spread, Kimberlin says.
www.medicalnewstoday.c...
Used to be that way. Now " Mis-measurement is the basis of science", if you're chasing grants or espousing an agenda (e.g. global warming).
I now have to cast a jaundiced eye on "science" just like I do politicians. If warming was the first case, I could be more forgiving. But add in Thalidomide, Alar, ... and it's hard not to become cynical.
HardToLove
Downgraded from Buy to Hold by Brean Murray.
Meant to list (KERX) as one of my newer investments, doing great since I picked it up last month.
---
ROCKVILLE, Md., April 7 /PRNewswire-FirstCall/ -- Novavax, Inc. (Nasdaq:NVAX - News) announced today that it has appointed James F. Young, Ph.D., to its Board of Directors. Dr. Young will be an independent Board Member effective immediately.
Dr. Young has over 30 years of experience in the fields of molecular genetics, microbiology, immunology and pharmaceutical development. He was previously President of Research and Development, including responsibility for regulatory affairs, at MedImmune where he was instrumental in the development of FluMist® and Synagis®. In 2005, Dr. Young was awarded the Albert B. Sabin Humanitarian Award. Prior to MedImmune, Dr. Young was influential in building the department of molecular genetics at Smith Kline & French Laboratories (now part of GlaxoSmithKline) and culminated as director, department of molecular genetics.
ProShares Launches First Leveraged and Inverse Biotechnology ETFs
www.marketwatch.com/st...
I haven't read the prospectus yet - don't know if co's of interest are included.
HardToLove
Let's hope this is a move back to at least the ~$2.45 range that I had hoped would provide the springboard for a break up.
I'm going to get short information updated (delayed due to being on the road) and will post the summary of change back here in a while.
HardToLove
I believe we're about to see the last board seat get filled (hopefully/probably with a major partnership announcement), and I suspect that's part of today's move as well.
It's just absurd how low NVAX share price is at this point.
- Short Qty- -Chg- Avg. Vol- -Days to cover
11,699,329 (4.60) 1,269,441 9.22
Average daily volume ~+20%, account for the drop from 11.56 days to cover.
Last three reporting periods all show reductions in short count. And prior periods were showing reductions 2 out of three times after 10/15 report (to that point, most periods showed increases).
HardTolove
I'll tell ya' though, patience is a difficult art in today's environment, as well as being essentially against my nature. But I'm holding and will play around my core for short-term gains as opportunities permit.
hardToLove
hondurasweekly.com/nat...
Also, SVA is creeping back up.
tinyurl.com/yegxpyu
1) Last week of trading days stayed above $2.25 and didn't re-visit the lower or sub $2 range.
2) Prior attempt to penetrate and then close above $2.40 failed, but today succeeded.
3) This last week has been consolidating around that $2.30 area with no extreme excursions to the downside and had two excursions to the upside, the last one (today) stuck it, closing at $2.44.
4) This was decent volume, 2.29MM, much larger than the typical <=~1MM we've been seeing *most* days recently.
5) Short *count* has established a fairly consistent down trend since last mid-October (see my comment above for a *brief* recap). A little more detail is seen in these % changes beginning with the Oct 30 report (covers 10/1-10/15): 5.04, -3.12, -6.87, 7.83, -5.06, -2.61, 5.32, -5.02, -1.9, -4.6.
6) As Mitshu noted, shorts are good at a stealth exit. So if they are not having much vertical effect on the price, and today had a good upward range ($2.45 high hit early in the a.m. and then the $2.42-$2.44 price range held all day long) and closed at $2.44, I think we have either fresh buyers entering or shorts (whom I presume know *at least* as much as we do) deciding they *better* start their exit now, or both situations.
7) # 6 says there is likely more near-term upside.
8) Technicals are starting to turn the way I like (but recall that I don't mind being early and riding the board on the turbulence a bit): RSI (54), MFI (69.87), Momentum (1.08) all flipped from neutral or had already flipped and continuing a positive divergence while (before today) prices were in net effect flat-lining; MACD has achieved neutrality after a long sojourn in the depths of Hello and even has a slight positive divergence (signal 0.0009, line 0.0054); stochastic made a positive cross yesterday - confirmed by today's action - after leaving oversold a couple days prior; accum/distr strongly negative (-30.62) but starting up on today's action; yesterday had a doji, indicating a change coming, combined with a narrowing of the bollinger bands, also indicating a change and today the price action and new bollinger range confirmed ($2.4474, $2.2886 - upper, lower).
9) The breakaway gap open 3/24 (low/high for the day $2.55 & $2.72, prior day high $2.35) indicates room to run to $2.55 and is the most recent resistance/support area; prior resistance (3/11) $2.58, $2.63 (2/19). I expect some at $2.50-$2.52 because of several prior touches at those points and I think it indicates a "psychological" level.
10) Trading above 20/50 SMAs ($2.3625 flat the last week, $2.3194 and starting to roll up now ... almost).
11) The shorts know as well as we what it means when later stage trials are started; they should not be heavily hammering anymore and should be in a concerted covering mode, barring any "black swan" events.
12) Options expiration week is next week; two previous one had a run up, the last had a run down.
My thinking is a one-month cycle trade, at most. This is because the price action history indicates a tendency to rise only a day or two and then do a little two-three step down. But over the month there seems to be at least one or two good upside moves. Expiration week used to be a good time to see prices rise, but that has become inconsistent.
My concern is that we don't conteract each other and don't alurk any lerters (spoonerism?:-).
I'm thinking a back-channel strategy session might be a handy thingy.
Thoughts?
HardToLove
Thanks, buddy!
(KERX) is looking up this morning, news could be pushing.
(VICL) is about due for some buzz this week...
tinyurl.com/yegxpyu
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