Dino could have done Better ?
I agree that news of some type is eminent
Question for the board
Why hasn't the RS been enacted
What do you make of the Scott-Grant post ,below
In regards to ( New facilities ) behind the scenes ?
i believe they are in very close contact with fda to make sure trials are exactly what they want for safety, this should have been approved already.. such a scam that it wasnt.. i guess a vaccine maybe fda being extra carefull but still weird.. maybe GSK will buy them.. this company growing bigtime and building new facilities.. behind the scenes.. get ready not the normal bio-tech.. this one is a clear winner.. patience is the game..
It's the Science
The TLR science has been proven valid.
The presence of Merck, GSK and AstraZ ALL validate that the TLR science is genuine.
Why would GSK promise $800MM on a science that was UN-VALIDATED, UNSAFE, UNPROVEN?
AZ has not left either and DVAX did nothing on their projects from 2009 until 2013.
Who WOULD stay 4 years waiting around for something which might not be VALID?
Dynavax gets HEP-LISA-V, FDA Approved the SCIENCE is worth BILLIONS
Do you know about SuperVax
That is sitting on a shelf
Or about our shelved universal Flu Vac
In April 2006, we completed the acquisition of Rhein Biotech GmbH, which we refer to as Dynavax Europe. As a result, we acquired a hepatitis B vaccine called SUPERVAX that has been tested in more than 600 subjects and has demonstrated safety and 99% seroprotection when administered on a two-dose schedule. SUPERVAX was launched in Argentina in December 2006 and is approved for marketing and sales through a third party partner. We intend to continue registration activities for SUPERVAX as a two-dose vaccine for adolescents for commercialization through partners in select countries outside of North America and Europe
There is more that we know
And who knows when news hits be Good or Bad *
List is a little dated but action or information about other candidates ?
You think you know ?
Dynavax's pipeline consists of five drug candidates: Heplisav, DV1179, AZ1419, SD-101, and DV230.
Hepatitis B vaccine
Phase 3 completed, NDA filed
Nanoparticle adjuvant technology
Universal Flu Vax
POM study in Lupus to be completed in Q3 2014
GSK has option to license the program after POM data
UP to 125 Million in renaming milestones plus royalties
GSK can exercise its exclusive option to license each program. If GSK exercises an option, GSK would carry out further development and commercialization of the corresponding products. If GSK exercises their option on the Lead TLR 7/9 program, then we are eligible to receive payments of up to approximately $125 million, comprised of contingent option exerc ise payments and additional payments based on GSK’s achievement of certain development, regulatory and commercial objectives
for mass vaccination programmes offered by international health organizations, such as UNICEF, for newborn children and infants.
Rhein Biotech has granted numerous research licenses and commercial licenses for the use of its Hansenula technology to companies including Serum Institute of India, Wockchard Limited (India) and Aventis Pasteur.
On the basis of its 3-dose Hepatitis B technology, the biotech company additionally developed a 2-dose Hepatitis B vaccine with a much faster onset of immuno-protection. The new vaccine will enter clinical trials at the end of 2006.
Rhein Biotech has become the third largest global producer of Hepatitis B vaccines worldwide. The success of Hansenula technology enabled the company to list on the Frankfurt Stock Exchange in 1999.
In addition to Hepatitis B vaccines, Rhein Biotech has developed production technologies for three other biopharmaceuticals, all based on Hansenula technology: Interferon alpha-2a, human insulin and Hirudin. The company’s licensees have successfully introduced the products into the market.
Further biopharmaceuticals may yet be developed using the technology. In the meantime, this invention has helped combat the spread of Hepatitis B worldwide through the development of a cost-effective vaccine production process, thanks to the work of scientists at Rhein Biotech.
The Market is very limited ?
According to World Health Organization estimates, more than one third of the world’s population is infected with Hepatitis B. Worldwide, 350 million people are chronic carriers of the virus. The disease can result in liver cirrhosis or cancer and in some cases, can be life-threatening. It can be transmitted by sexual contact, shared needles, or contaminated blood products. Doctors, or those working with blood, are at risk.
Prophylactic vaccination is generally considered to be the best means to control the spread of this severe, viral liver disease. However, existing recombinant vaccines were considered too expensive for mass vaccination programmes until scientists came up with a new, cost-effective vaccine technology.
The scientists, namely Zbigniew Janowicz, and Professor Cornelius Hollenberg, invented a process for the production of foreign proteins in Hansenula yeast. The technology allows for a high-yield production process. The result is a pure vaccine, which is free of pathogens and can be safely administered without using a needle. The method is deemed essential for the development of recombinant gene expression and processes for the production of proteins, especially active pharmaceutical ingredients.
The Hansenula technology was granted a patent in 1994. A number of commercial biopharmaceutical and biotech applications now use Hansenula polymorpha yeast expression technology. The method is acknowledged as an industrial standard for protein production.
The invention of Hansenula technology enabled the introduction of standard vaccination programmes to counter the spread of Hepatitis B disease worldwide. Rhein Biotech GmbH, a spin-off of the University of Düsseldorf, first developed a 3-dose Hepatitis B vaccine using the method at the start of the 1900s. The company then licensed the technology to Korea Green Cross, one of its subsidiaries. Korea Green Cross became the first company to offer an affordable Hepatitis B vac
Straight from the Horse's mouth
From the Q
Because only 0.1% of the authorized shares under our Certificate of Incorporation remain available for issuance, we require additional available authorized shares of common stock to provide for any potential future stock issuances to raise capital, (effect acquisitions) and/or provide equity incentives to our employees. At present, we do not have any plans or arrangements to issue additional shares of common stock other than shares currently reserved for issuance under our existing equity incentive plans and upon conversion of our outstanding Series B convertible preferred stock and warrants
China indicts US, British corporate investigators
China indicts US, British corporate investigators for illegally obtaining private information
By Gillian Wong, Associated Press
16 minutes ago
BEIJING (AP) -- Chinese authorities have indicted British and American investigators hired by GlaxoSmithKline on charges of illegally obtaining and selling private information, state media reported Monday, as the Briton blamed the pharmaceutical company for misleading and using him.
British investigator Peter Humphrey and his wife Yingzeng Yu, a U.S. citizen, were charged in Shanghai's No. 1 Intermediate People's Court, the official Xinhua News Agency said. It said this is the first time foreigners have faced such charges.
Humphrey, 58, and Yu, 61, are part of an industry of investigators who help corporate clients screen potential partners and employees or watch for embezzlement and other employee misconduct.
Their arrest last year coincided with a Chinese investigation of accusations that GlaxoSmithKline paid bribes to doctors and officials to use its medications. Glaxo said it hired Yu and Humphrey last year to investigate a security breach involving a top manager.
The indictment received prominent coverage in China. Reports by state broadcaster CCTV showed Humphrey and Yu being separately interviewed by Chinese reporters. They were shown seated and wearing orange vests that are typical uniforms of detainees as they spoke to reporters.
The couple, who ran a Shanghai firm, ChinaWhys Ltd., were accused of illegally selling a "huge amount" of personal information on Chinese citizens, Xinhua said. It said that included home addresses, information about family members, details about real estate and vehicles and records of travelers entering and leaving the country.
Prosecutors say they obtained such information by illegally buying it from others as well as with hidden cameras or by following people, Xinhua said. It said they would sell the reports to clients that were mainly multinational companies in China such as GSK China.
In Chinese media reports on Monday, Humphrey said he was contacted in April 2013 by GSK's then-China manager, Mark Reilly, who wanted him to find out who leaked allegations of bribery at the firm to Chinese authorities and senior executives at the firm.
Reilly, who is British, is at the center of a major investigation into corruption in China's medical industry. In May, he was accused of leading a sprawling scheme to bribe doctors and hospitals to use GSK's drugs. Reilly's case has been turned over to prosecutors.
Humphrey said on state television that he found out during his investigation that the bribery claims were true and if he had known that earlier he would not have carried out the probe. Humphrey said he felt "betrayed and used" by the pharmaceutical firm.
In a written response to a request for comment, Glaxo cited a July 3 statement that said Humphrey and Yu's firm was hired in April 2013 to investigate "a serious breach of privacy and security related to" Reilly.
"They were not hired to investigate the substance of the allegations of misconduct made by the whistleblower," the company said in an email.
The British Embassy in Beijing said it was providing consular help to Humphrey and his family and have told Chinese authorities they would like to attend the trial, which the court has said will be closed. A trial date hasn't been announced yet.
"We have made clear to the Chinese authorities that we would like Embassy staff to attend the trial and the need for a transparent and fair process," the embassy said in an emailed response to questions.
As we rise to the 4.00 area over the next 12 months ( without any AE. )
Company implements a 10 for 1 and " If we hit" you have a 80.00 dollar stock
A 1 for 10 would make for a 24 Million share float
You do realize that 70 to 80 % is held by institutions and if it is a high dollar stock that will increase.
Shares will be
Hard to borrow
And Hard to get
This is the perfect storm *
Rode SIRI from .35 to 2.85 been out for for some TIME *
SIRI bought me Two rent homes on MAUI
Needless to say I'm a LIFE TIME subscriber to SIRI