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Good morning Sheff!
Have you raised your target on BDSI from $10?
Pre-market looks very strong @ mid 8's or +23%
GLTA
Investor 100
Solid News today @ Nighthawk!
Building key relationships and securing more business in this region of the country!
I like the large order of 500 units...keep it coming!
GLTA
Investor 100
BioDelivery Sciences International, Inc. Reaches Agreement on REMS With FDA Review Division
6:00am EDT
BioDelivery Sciences International, Inc. announced that it has reached agreement with the U.S. Food and Drug Administration's (FDA) Division of Anesthesia, Analgesia and Rheumatology Products and a multidisciplinary review team on all aspects of the Company's New Drug Application (NDA) for ONSOLIS (fentanyl buccal soluble film), including the Risk Evaluation and Mitigation Strategy (REMS). Although the FDA did not meet its action date of last for this NDA, the Division has informed the Company that FDA will not be issuing a review extension letter as their action on the NDA is forthcoming. BDSI received a Complete Response letter from FDA on the NDA for ONSOLIS on August 28, 2008, with the only deficiency being the new requirement for a REMS. The REMS was not required at the time the NDA was originally submitted to FDA in October 2007. The REMS was formally submitted to the FDA on December 12, 2008 and the submission was placed under a six month review period.
Pre-Market @ BDSI Up 23%
Much anticipation this morning shows some steady growth at BDSI trading in the low 8's!
Much success to all that hold shares!
Investor 100
Pfizer eyes deals to raise emerging markets presence
The big players such as Pfizer are looking to grow with more acquisitions..interesting sector for sure!
http://www.reuters.com/article/newsOne/idUSTRE55D0VM20090614
Investor 100
Transparency in shareholder communication would create much more interest in this stock.
With Flotation Technology a key component with its expansion program and ground breaking ceremony with the states governor complimenting the company success and employment record all news should be broadcast to the investment community...what a shame!
Not sure how much of a bounce this stock might experience given that hurricane season is approaching.
Please to see some new names but also some old ones too!
GLTA
Investor 100
Fantastic Sheff!
What a difference in six months following your path to success and making some serious money has created.
I have a hunch that you might be getting a call from Wall Street asking how you do it (LOL).
I too have enjoyed the run and look forward to reviewing the numbers in December.
Me, holding BDSI - NEPH - KERX - HEB
Terrific board with transparency and money making stock choices!
GLTA
Investor 100
Solid Interview w/CEO Carter
Spoke with conviction and complete understanding of his products without question.
( former professor at MIT- no dummy running the show )
He states that 80% approval at this stage of FDA approval however does not have a time frame as to when FDA might make their announcement.
Ramping up production at its manufacturing facility for possible production request for both CFS and H1N1 potential opportunity.
Expanding and increasing staff to be announced next week with much excitement.
Raising 150M shelf offering to be prepared for strategic relationships / alliances and expansion of products an production...interesting!
Well informed with relationship with Japanese government who solicited HEB for assistance not vice-versa.
I have and continue to be convinced that the future looks strong @ HEB so I am staying the course with my holdings.
GLTA
Investor 100
Another dip another opportunity!
Added another 500 shares @ BDSI
Solid Day today for BDSI and NEPH
Setting up nice for next week:)
Great board Sheff!
Good weekend all!
Investor 100
Like a cork on champagne!
Should be fun to watch and play Sheff!
GLTA
Investor 100
Shorts @ NEPH
http://www.shortsqueeze.com/?symbol=neph
Investor 100
Took advantage of the dip!
Added another 500 shares @ BDSI.
GLTA
Investor 100
Ditto Kate!
Investor 100
Double Dip Today Sheff!
Steady as a ship NEPH & BDSI :)
Solid DD to make some money!
Happy Friday
Investor 100
Solid Day @ BDSI
Bingo $7!
Steady as she goes...nice DD on this one Sheff.
Another feather in your cap + wallet!
In for 500 shares.
GLTA
Investor 100
Steady Growth @ BDSI
Nice steady upward movement today Sheff!
Another solid selection to make some money and help the world!
GLTA
Investor 100
Hemispherx Biopharma Press Release for
Friday, June 12, 2009
Hemispherx’s Collaborative Partner in Japan, Biken Corp., Expands Production Capacity for Swine/Avian Flu Vaccines
…WHO Raises Threat of Swine Flu to Pandemic Level
Philadelphia, PA, Friday, June 12, 2009: Hemispherx Biopharma (NYSE AMEX: HEB) announced today that its collaborative influenza vaccine development partner in Japan, Biken, has decided to expand its Flu production capacity significantly.
On June 9, 2009, Biken issued the following press release in Japan (translated as follows): “Biken decided to expand its manufacturing facilities in Kanonji City. Biken will invest a total of 35 billion Yen (US $350 million) expecting to complete in 2013. Manufacturing capacities will be scaled up by 5 times, so as to be ready to manufacture Swine/Avian Flu vaccine for 60 million people within 6 months. New facilities will focus on the cell culture technology instead of the current poultry egg culture”.
According to Japanese research teams, directed by Dr. Hasegawa of the Japanese National Institute of Infectious Diseases (JNIID) and as published in a various peer-reviewed publications and presented at scientific conferences, Ampligen®, an experimental therapeutic, is an essential co-ingredient to provide experimental efficacy with the Biken vaccine. An updated peer reviewed list of the JNIID publications on this topic is being made available by accessing the Hemispherx web site: www.hemispherx.net.
Hemispherx has a broad global portfolio of pending intellectual property on the subject which includes both field of therapeutic use and composition of elemental matter on Ampligen®, an experimental therapeutic, as well as its congeners (closely related compounds).
Yesterday, the World Health Organization (WHO) raised the threat level of swine flu to its highest level, level 6.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is a specialty pharma company engaged in the manufacture and clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx's flagship products include Alferon N Injection® (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics, Ampligen® and Oragens. Ampligen® and Oragens represent experimental RNA nucleic acids being developed for globally important debilitating diseases and disorders of the immune system. Hemispherx's platform technology includes large and small agent components for potential treatment of various severely debilitating and life threatening diseases. Hemispherx has in excess of 50 issued patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection®). The Company wholly owns and exclusively operates a GMP certified manufacturing facility in the United States for commercial products. For more information please visit www.hemispherx.net.
Contact:
Hemispherx Biopharma, Inc.,
Dianne Will, Investor Relations
(518) 398-6222, Fax: (518) 398-6369
HEB's Web Site: www.hemispherx.net
Interesting Development @ Japan!
Today's news in Japan is solid news for HEB according to the June 4th,press release!
Buying more as we speak!!
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Japanese National Institute of Infectious Diseases Scientists Identify Hemispherx Biopharma’s Drug Technology as the “Most Promising Mucosal Adjuvant for Influenza”
.....Topical Application Also Affords Strong Cross-Protection against Variant Flu Strains
Philadelphia, PA, Thursday, June 04, 2009: Hemispherx Biopharma (NYSE AMEX: HEB) announced today that a new peer reviewed publication titled “Development of mucosal adjuvants for intranasal vaccine for H5N1 influenza viruses” was published in Therapeutics and Clinical Risk Management 2009:5 125-132. The article summarizes ongoing research in which researchers conclude that Poly I:PolyC12U (Ampligen®), an experimental therapeutic, is the “most promising adjuvant candidate for mucosal vaccines.” Poly I:PolyC12U (Ampligen®), an experimental therapeutic, was also” extremely important” in these studies in that it produced cross-protection against variant influenza viruses not seen with the vaccines given alone.
Mucosal immunity has many potential advantages (please see Nature Medicine, supplement article titled “Mucosal Immunity and Vaccines” Vol. 11, number 4, pp. S45-S53). These advantages include a better stimulation of natural immunity than conventionally applied vaccines (intramuscular injection). Since most infections affect or start from a mucosal surface, topical application is often required to induce a protective immune response. However, in practice, it is often difficult to stimulate a strong SIgA immune response by mucosal administration of antigens given alone. Injectable vaccines can also give severe local reactions and the magnitude/ duration of protection may be less by parenteral (needle) delivery than by the topical application described by the JIID researchers.
The conclusion of the JIID researchers is that a pandemic of new influenza virus seems possible, and because it will be difficult to know when a pandemic will occur (or which strain of virus will be the cause), it is in the global community’s best interest to develop broadly effective and safe vaccines against influenza virus. Hence, in the need for development of a broadly effective vaccine, induction of mucosal immunity is an inevitable requirement, as mucosal secretory IgA plays an important role in cross protection. Vaccines designed to induce mucosal immunity are necessary, in the JIID view, to combat a new influenza pandemic.
Today, Hemispherx Biopharma is summarizing its new influenza prevention/ treatment data at a special Symposium on Pandemic Influenza in Rome under auspices of the Italian Government which will include an update on the Japanese collaborations.
Solid Point Stockpicker-
The global response is going to take the efforts of all companies to combat this problem.
For the US I have to believe that President B. Obama will ask all drug companies to participate in this effort and perhaps HEB will be included.
For HEB this opportunity is more than receiving FDA approval for CFS as it is not a "one pony show".
I am holding, adding shares on dips.
Buckled in for the ride today!
Investor 100
Flu pandemic? U.S. has been there for weeks
WASHINGTON (Reuters) - The World Health Organization may have just declared a pandemic of the H1N1 flu virus, but the United States has been acting as if a pandemic was under way for weeks, health officials said on Thursday.
The new swine flu virus was first identified in two U.S. children in April and by the time the news was out, it had already begun spreading. CDC experts estimate that hundreds of thousands of people are likely infected in every state.
Although most had mild symptoms, there have been at least 27 deaths and 1,000 people have been sick enough to be hospitalized.
Dr. Thomas Frieden, who has been in his job as CDC director for just four days, told a news conference the WHO declaration did not come as a surprise. "There are no practical implications for most state and local governments," he added.
"Here in the United States, the basic declaration isn't going to change our day-to-day activities," added the CDC's Dr. Anne Schuchat.
WHO raised its pandemic flu alert to phase 6 on a six-point scale, indicating the first influenza pandemic since 1968 is under way.
Based on the U.S. experience, what can the rest of the world expect?
The new H1N1 disproportionately makes younger people sick. Schuchat said 57 percent of U.S. cases were among people aged 5 to 24, and 41 percent of those hospitalized were in this younger age group.
"The highest rates of hospitalization are actually in children under 5," Schuchat said. Pregnant women, people with asthma or other chronic respiratory disease and diabetics needed to take special care and call a doctor if they had symptoms.
H1N1 is active in all 50 states and there are so many cases now that in some areas, patients with specific flu-like symptoms -- a fever above 104 degrees F, cough or other respiratory symptoms -- are presumed to have the new virus.
YEARS OF PLANNING
The United States, like other countries, has been planning for an influenza pandemic for years.
Stockpiles were made of antiviral drugs -- Roche AG and Gilead Sciences Inc.'s Tamiflu and GlaxoSmithKline and Biota's Relenza -- and state, local and federal officials held distribution exercises.
Work on an H1N1 vaccine is under way. The Health and Human Services Department has ordered $650 million worth of vaccine ingredients from its five corporate suppliers and $287 million worth of boosters called adjuvants that can be used to make vaccines work better.
Schuchat said there had been "some challenges" but did not elaborate. CDC and the Association of State and Territorial Health Officers plan a series of "lessons learned" meetings, she said. "I think this will be really vital information to help us react better in the fall," Schuchat said.
There may be good information for health officials in the Southern Hemisphere, where flu season is just getting under way, she said. Other pandemics have started out as a moderate flu season in the spring, only to surge back and be more deadly in the autumn.
One big worry is that seasonal H1N1 and H3N2 viruses are still circulating. The seasonal H1N1 has mutated into a form that resists Tamiflu, although it is still susceptible to Relenza.
Schuchat and other experts fear if someone got infected with two strains at the same time, the viruses could recombine in the patient's body and acquire new strengths and new drug resistance. "We really don't want this novel H1N1 to become resistant to Tamiflu as well," Schuchat said.
Chronic Fatigue Syndrome (CDC)
http://www.cdc.gov/CFS/
A variety of studies by CDC and others have shown that between 1 and 4 million Americans suffer from Chronic Fatigue Syndrome (CFS). They are seriously impaired, at least a quarter are unemployed or on disability because of CFS. Yet, only about half have consulted a physician for their illness. The earlier a person with CFS receives medical treatment the greater the likelihood that the illness will resolve. Equally important, about 40% of people in the general population who report symptoms of CFS have a serious, treatable, previously unrecognized medical or psychiatric condition (such as diabetes, thyroid disease, substance abuse). CFS is a serious illness and poses a dilemma for patients, their families, and health care providers. This web site aims to provide evidence-based information concerning the illness, its manifestations, and treatment.
FDA Pre-Market Notification (510k) Information
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm
Investor 100
Shake,,Shake,,Shake...
President Speaking on Health Care ( CNN )
Probably in response to WHO announcement ( assuming )
Investor 100
Swine flu 'not stoppable,' World Health Organization says
( Updated 1:12pm )
I wonder if this bodes well with HEB & Japanese government who have concluded that they are impressed with HEB results..do we have a contract coming up with Japan..hmmm
This is not a "one trick pony" stock (IMO)
This is terrible news for the world and I wish phase #6 was not announced..prayers are in order!!
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(CNN) -- The World Health Organization raised the swine flu alert Thursday to its highest level, saying the H1N1 virus has spread to enough countries to be considered a global pandemic.
Kindergarten students, some wearing masks, attend school in a residential estate in Hong Kong on Thursday.
Kindergarten students, some wearing masks, attend school in a residential estate in Hong Kong on Thursday.
Increasing the alert to Phase 6 does not mean that the disease is deadlier or more dangerous than before, just that it has spread to more countries, the WHO said.
"This is an important and challenging day for all of us," WHO Director General Margaret Chan said in a briefing with reporters. "We are moving into the early days of the first flu pandemic of the 21st century."
As of Wednesday evening, the virus had spread to 74 countries, the health agency said. There were 27,737 confirmed cases and 141 deaths.
The United States had 13,217 cases and 27 deaths, the Centers for Disease Control and Prevention said Friday in its weekly update. Cases have been reported in all 50 states, the District of Columbia and Puerto Rico.
"Further spread is considered inevitable," Chan said at a news conference at WHO headquarters in Geneva, Switzerland. "The scientific criteria for an influenza pandemic have been met."
The announcement came after a meeting of the WHO's Emergency Committee, which has debated since April whether the spread of a novel H1N1 flu virus was fast and widespread enough to warrant a Phase 6 designation.
Phase 6, Chan said, is meant as a signal to countries to recalibrate their strategies to minimize the harm from swine flu. In countries where the virus and the response to it are already widespread, it is not likely to mean significant changes, but Chan urged countries that have not seen cases, or seen only limited cases, to get ready.
"The virus is not stoppable," she said. "I would advise them to maintain vigilance, enhance surveillance and be prepared for the arrival of the novel H1N1 in their country."
The U.S. Department of Health and Human Services and the Department of Homeland Security said those agencies have been acting for weeks as if Phase 6 were already in effect and no additional measures would be put into effect.
The United States declared a public health emergency April 26.
"WHO continues to recommend no restriction on travel and on border closures," Chan said.
Discussions about shifting to Phase 6 have been under way for weeks. Chan indicated that a major factor in the decision was surveillance from countries in the Southern Hemisphere, where flu season is under way. In Chile and Australia, two countries with many flu cases, she said H1N1 appears to be the dominant strain, "crowding out" the seasonal influenza virus.
Chan said she would recommend that vaccine manufacturers proceed with mass production of an inoculation against the new swine flu strain as soon as they finish production of seasonal vaccine, which she estimated would be complete in about two weeks.
HHS spokesman Bill Hall said Thursday that no decision has been made on full-scale production because there is no need yet to make that decision.
It is a step-by-step process that is moving forward. "We're doing as much as we can now," he said.
The agency awarded a contract several weeks ago to five manufacturers to develop an H1N1 antigen. The companies are producing pilot lots. Clinical testing will take place over the summer, Hall said.
At the end of the summer, HHS will decide whether to go into production.
"There's no specific date on the calendar," Hall said.
If officials decide to produce a vaccine, the first doses would be ready early in the fall. Hall noted that even full-scale production doesn't mean there will be an immunization campaign. Federal officials may have a vaccine and decide not to use it, he said.
Also Thursday, authorities in Hong Kong ordered the closure of all elementary schools, kindergartens and day care centers in the city after 12 students were found to be infected with the virus.
Authorities have not determined the source of the infection, said Hong Kong's Chief Executive Donald Tsang. This makes it the first cluster of swine flu cases in the city without a link to someone who had traveled overseas.
The schools and day care centers were told to close for 14 days as investigators tried to identify the source of the infection, said Tsang, the chief executive.
The health department will decide after two weeks whether or not to continue the shutdown.
Also on Thursday, Israel's health ministry announced that the number of people diagnosed with swine flu there was 68.
Health officials use the virus' clinical name -- H1N1 -- to reflect that it's actually a combination of several different types of flu and to reduce confusion about whether eating pork can spread the virus. It cannot.
CNN's David S. Martin, Roya Shadravan in Hong Kong, and Michal Zippori in Jerusalem contributed to this report.
All About World Health Organization • Swine Flu
Solid Day @ Sheff's Board!
Bought 500 shares of BDSI on the short dip!
Strength is building this afternoon:)
GLTA
Investor 100
I am pleased at the details and quick response time on their part considering the phones and e-mails must be quite busy given the interest on a global scale!
I am buckled in for the ride.
GLTA
Investor 100
Quick response from HEB IR Dept
Timeframes by the FDA are simply guidelines – nothing more, nothing less. I
believe they do try to adhere to these dates, but they miss more than they make.
This is widely known on Wall Street.
The company has not reported any additional information since May 26th, because
there simply is nothing more to report.
As soon as they do, the company will make an announcement.
The SEC requires public companies to report material events within four business
days. In the case of Hemispherx and the FDA pending decision, the company will
need to disseminate the information from the FDA and possibly speak with them if
there are any questions. A press release will then need to be drafted and
signed off on by people within the company, then the will be reported to the
shareholders.
The company will make an announcement as soon as they are able.
I agree Sheff!
I added another 2500 shares this morning given the dip!
Watching BDSI for a position!
GLTA
Investor 100
Good morning!
Should have some news on WHO decision as to raising the phase #6
If so will that help push HEB PPS up...hmmm
As they say " no news is good news" but in our case "no news is no news"
It is a waiting game..poker call!
GLTA
Investor 100
Oil near $72 on economic recovery hopes
Oil hovers near $72 in Asia on investor optimism for an economic recovery
Alex Kennedy, Associated Press Writer
On Thursday June 11, 2009, 4:57 am EDT
Buzz up! Print.SINGAPORE (AP) -- Oil prices hovered near $72 a barrel Thursday in Asia as investor optimism about a global economic recovery pushed crude to fresh highs for the year.
Benchmark crude for July delivery rose as high as $72.18 a barrel and was up 62 cents to $71.95 by late afternoon Singapore time in electronic trading on the New York Mercantile Exchange. On Wednesday, it rose $1.32 to settle at $71.33.
Oil has jumped from below $35 a barrel in March on expectations the worst of a severe U.S. recession was over. Traders are now beginning to price in a recovery by the end of the year and improving crude demand, analysts said.
"Investors are expecting a quick turn around," said Ben Westmore, an energy analyst with National Australia Bank in Melbourne. "If the data in the coming months shows there isn't a quick rebound, the oil price should fall."
Poor trade numbers from China on Thursday suggest a global economic recovery could be slower that some investors were expecting. Chinese exports fell 26.4 percent in May from a year earlier while imports dropped 25.2 percent, the customs agency said.
The Energy Department's Energy Information Administration said Wednesday that crude inventories fell 1.6 million barrels in the week ended June 5. Analysts had expected a build of 800,000 barrels.
Crude stocks have fallen four straight weeks, suggesting U.S. crude demand could be recovering.
"We might be seeing the early signs of a trend," Westmore said.
Investors have also sought crude as a hedge against inflation on fears massive fiscal stimulus spending could weaken the U.S. dollar. The euro gained to $1.4029 on Thursday from 1.3990 the previous day.
Iran and Kuwait, members of the Organization of Petroleum Exporting Countries, said Wednesday the group may raise output if oil prices keep rising. OPEC slashed output 4.2 million barrels a day between September and January in a bid to bolster prices.
In other Nymex trading, gasoline for July delivery rose 1.47 cents to $2.03 a gallon and heating oil gained 0.49 cent to $1.84. Natural gas for July delivery was steady at $3.71 per 1,000 cubic feet.
SOURCE:
http://finance.yahoo.com/news/Oil-near-72-on-economic-apf-15497307.html?sec=topStories&pos=1&asset=&ccode=
Deep Down Inc Power Point Presentation
Comprehensive Review of DDI Business Model:
http://www.docstoc.com/docs/6847850/Deep-Down
Investor 100
Holdings/Transactions
Does it make sense that these folks ( unknown ) make such an investment into HEB last Thursday without FDA approval?
Carter's purchase is a sign of confidence (IMO)
http://www.mffais.com/heb
The jury is out until the FDA makes its announcement(s).
GLTA
Investor 100
FDA tag for reference
Means this is the tag where you will find the approval so keep it as reference - nothing more - nothing less.
Investor 100
FDA drug approvals for June 2009
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Reports.MonthlyApprovalsAll
National Institute of Infectious Diseases
http://idsc.nih.go.jp/disease/swine_influenza_e/case-e-2009/090610case_e.html
(Results for Japan)
The FDA under Bush had been known to rush to judgement too quickly ( i.e. Merck ) so I think they want to get it right since we have a new administration on-board!
All good, one has to be sure what they own here..we are taking lives for those that need this medicine!
GL
Investor 100
If I remember the FDA had initially asked for additional information from the initial data ( that is positive ).
My feeling (IMO) is if they did not like the additional information they would have declined it outright and we would have heard the news during the two week delay.
I think we will see a delay given that they have perhaps more questions or need more clarification ( all good )
I am long and waiting like the rest!
Investor 100
Announcement at Shareholder Meeting?
Two weeks from today at the annual shareholder meeting much will be discussed (IMO).
Anybody on this board planning to attend?
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2009 Hemispherx Biopharma Annual Shareholders Meeting
Hemispherx's 2009 Annual Meeting of Stockholders to be held at the Embassy Suites Hotel, 1776 Benjamin Franklin Parkway, Philadelphia, Pennsylvania 19103, on Wednesday, June 24, 2009, at 10:00 a.m. EDT.
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Investor 100