Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
There may be a secondary but I doubt it would come prior to Novavax gaining the recognition of it's greatly increased value from the news about to get released over the next week. We could also see RSV Maternal get outside funding from PATH or elsewhere. Let's see how the next week plays out before we discuss funding.
One factor that has not been appreciated is the fact that Novavax with the breath and size of the recent Adult RSV trial has essentially Aced a Phase 3 Clinical Trial. Even the doubting Lobster was blown away by this successful trial. This company is clearly going to bring to market a very large vaccine. Bill
Sentiment: Strong Buy
Full shareholder's meeting is required.
TITLE 8
Corporations
CHAPTER 1. GENERAL CORPORATION LAW
Subchapter VIII. Amendment of Certificate of Incorporation; Changes in Capital and Capital Stock
§ 241 Amendment of certificate of incorporation before receipt of payment for stock.
(a) Before a corporation has received any payment for any of its stock, it may amend its certificate of incorporation at any time or times, in any and as many respects as may be desired, so long as its certificate of incorporation as amended would contain only such provisions as it would be lawful and proper to insert in an original certificate of incorporation filed at the time of filing the amendment.
(b) The amendment of a certificate of incorporation authorized by this section shall be adopted by a majority of the incorporators, if directors were not named in the original certificate of incorporation or have not yet been elected, or, if directors were named in the original certificate of incorporation or have been elected and have qualified, by a majority of the directors. A certificate setting forth the amendment and certifying that the corporation has not received any payment for any of its stock, or that the corporation has no members, as applicable, and that the amendment has been duly adopted in accordance with this section shall be executed, acknowledged and filed in accordance with § 103 of this title. Upon such filing, the corporation's certificate of incorporation shall be deemed to be amended accordingly as of the date on which the original certificate of incorporation became effective, except as to those persons who are substantially and adversely affected by the amendment and as to those persons the amendment shall be effective from the filing date.
(c) This section will apply to a nonstock corporation before such a corporation has any members; provided, however, that all references to directors shall be deemed to be references to members of the governing body of the corporation.
8 Del. C. 1953, § 241; 56 Del. Laws, c. 50; 64 Del. Laws, c. 112, § 23; 70 Del. Laws, c. 587, § 13; 77 Del. Laws, c. 253, §§ 31, 32.;
§ 242 Amendment of certificate of incorporation after receipt of payment for stock; nonstock corporations.
(a) After a corporation has received payment for any of its capital stock, or after a nonstock corporation has members, it may amend its certificate of incorporation, from time to time, in any and as many respects as may be desired, so long as its certificate of incorporation as amended would contain only such provisions as it would be lawful and proper to insert in an original certificate of incorporation filed at the time of the filing of the amendment; and, if a change in stock or the rights of stockholders, or an exchange, reclassification, subdivision, combination or cancellation of stock or rights of stockholders is to be made, such provisions as may be necessary to effect such change, exchange, reclassification, subdivision, combination or cancellation. In particular, and without limitation upon such general power of amendment, a corporation may amend its certificate of incorporation, from time to time, so as:
(1) To change its corporate name; or
(2) To change, substitute, enlarge or diminish the nature of its business or its corporate powers and purposes; or
(3) To increase or decrease its authorized capital stock or to reclassify the same, by changing the number, par value, designations, preferences, or relative, participating, optional, or other special rights of the shares, or the qualifications, limitations or restrictions of such rights, or by changing shares with par value into shares without par value, or shares without par value into shares with par value either with or without increasing or decreasing the number of shares, or by subdividing or combining the outstanding shares of any class or series of a class of shares into a greater or lesser number of outstanding shares; or
(4) To cancel or otherwise affect the right of the holders of the shares of any class to receive dividends which have accrued but have not been declared; or
(5) To create new classes of stock having rights and preferences either prior and superior or subordinate and inferior to the stock of any class then authorized, whether issued or unissued; or
(6) To change the period of its duration; or
(7) To delete:
a. Such provisions of the original certificate of incorporation which named the incorporator or incorporators, the initial board of directors and the original subscribers for shares; and
b. Such provisions contained in any amendment to the certificate of incorporation as were necessary to effect a change, exchange, reclassification, subdivision, combination or cancellation of stock, if such change, exchange, reclassification, subdivision, combination or cancellation has become effective.
Any or all such changes or alterations may be effected by 1 certificate of amendment.
(b) Every amendment authorized by subsection (a) of this section shall be made and effected in the following manner:
(1) If the corporation has capital stock, its board of directors shall adopt a resolution setting forth the amendment proposed, declaring its advisability, and either calling a special meeting of the stockholders entitled to vote in respect thereof for the consideration of such amendment or directing that the amendment proposed be considered at the next annual meeting of the stockholders; provided, however, that unless otherwise expressly required by the certificate of incorporation, no meeting or vote of stockholders shall be required to adopt an amendment that effects only changes described in paragraph (a)(1) or (7) of this section. Such special or annual meeting shall be called and held upon notice in accordance with § 222 of this title. The notice shall set forth such amendment in full or a brief summary of the changes to be effected thereby unless such notice constitutes a notice of internet availability of proxy materials under the rules promulgated under the Securities Exchange Act of 1934 [15 U.S.C. § 78a et seq.]. At the meeting a vote of the stockholders entitled to vote thereon shall be taken for and against any proposed amendment that requires adoption by stockholders. If no vote of stockholders is required to effect such amendment, or if a majority of the outstanding stock entitled to vote thereon, and a majority of the outstanding stock of each class entitled to vote thereon as a class has been voted in favor of the amendment, a certificate setting forth the amendment and certifying that such amendment has been duly adopted in accordance with this section shall be executed, acknowledged and filed and shall become effective in accordance with § 103 of this title.
(2) The holders of the outstanding shares of a class shall be entitled to vote as a class upon a proposed amendment, whether or not entitled to vote thereon by the certificate of incorporation, if the amendment would increase or decrease the aggregate number of authorized shares of such class, increase or decrease the par value of the shares of such class, or alter or change the powers, preferences, or special rights of the shares of such class so as to affect them adversely. If any proposed amendment would alter or change the powers, preferences, or special rights of 1 or more series of any class so as to affect them adversely, but shall not so affect the entire class, then only the shares of the series so affected by the amendment shall be considered a separate class for the purposes of this paragraph. The number of authorized shares of any such class or classes of stock may be increased or decreased (but not below the number of shares thereof then outstanding) by the affirmative vote of the holders of a majority of the stock of the corporation entitled to vote irrespective of this subsection, if so provided in the original certificate of incorporation, in any amendment thereto which created such class or classes of stock or which was adopted prior to the issuance of any shares of such class or classes of stock, or in any amendment thereto which was authorized by a resolution or resolutions adopted by the affirmative vote of the holders of a majority of such class or classes of stock.
(3) If the corporation is a nonstock corporation, then the governing body thereof shall adopt a resolution setting forth the amendment proposed and declaring its advisability. If a majority of all the members of the governing body shall vote in favor of such amendment, a certificate thereof shall be executed, acknowledged and filed and shall become effective in accordance with § 103 of this title. The certificate of incorporation of any nonstock corporation may contain a provision requiring any amendment thereto to be approved by a specified number or percentage of the members or of any specified class of members of such corporation in which event such proposed amendment shall be submitted to the members or to any specified class of members of such corporation in the same manner, so far as applicable, as is provided in this section for an amendment to the certificate of incorporation of a stock corporation; and in the event of the adoption thereof by such members, a certificate evidencing such amendment shall be executed, acknowledged and filed and shall become effective in accordance with § 103 of this title.
(4) Whenever the certificate of incorporation shall require for action by the board of directors of a corporation other than a nonstock corporation or by the governing body of a nonstock corporation, by the holders of any class or series of shares or by the members, or by the holders of any other securities having voting power the vote of a greater number or proportion than is required by any section of this title, the provision of the certificate of incorporation requiring such greater vote shall not be altered, amended or repealed except by such greater vote.
(c) The resolution authorizing a proposed amendment to the certificate of incorporation may provide that at any time prior to the effectiveness of the filing of the amendment with the Secretary of State, notwithstanding authorization of the proposed amendment by the stockholders of the corporation or by the members of a nonstock corporation, the board of directors or governing body may abandon such proposed amendment without further action by the stockholders or members.
8 Del. C. 1953, § 242; 56 Del. Laws, c. 50; 57 Del. Laws, c. 148, §§ 18-21; 59 Del. Laws, c. 106, § 7; 63 Del. Laws, c. 25, § 12; 64 Del. Laws, c. 112, § 24; 67 Del. Laws, c. 376, § 10; 70 Del. Laws, c. 349, §§ 5-7; 70 Del. Laws, c. 587, § 14, 15; 72 Del. Laws, c. 123, § 5; 77 Del. Laws, c. 253, §§ 33-35; 77 Del. Laws, c. 290, § 7; 79 Del. Laws, c. 327, § 6.;
§ 243 Retirement of stock.
(a) A corporation, by resolution of its board of directors, may retire any shares of its capital stock that are issued but are not outstanding.
(b) Whenever any shares of the capital stock of a corporation are retired, they shall resume the status of authorized and unissued shares of the class or series to which they belong unless the certificate of incorporation otherwise provides. If the certificate of incorporation prohibits the reissuance of such shares, or prohibits the reissuance of such shares as a part of a specific series only, a certificate stating that reissuance of the shares (as part of the class or series) is prohibited identifying the shares and reciting their retirement shall be executed, acknowledged and filed and shall become effective in accordance with § 103 of this title. When such certificate becomes effective, it shall have the effect of amending the certificate of incorporation so as to reduce accordingly the number of authorized shares of the class or series to which such shares belong or, if such retired shares constitute all of the authorized shares of the class or series to which they belong, of eliminating from the certificate of incorporation all reference to such class or series of stock.
(c) If the capital of the corporation will be reduced by or in connection with the retirement of shares, the reduction of capital shall be effected pursuant to § 244 of this title.
8 Del. C. 1953, § 243; 56 Del. Laws, c. 50; 57 Del. Laws, c. 149; 57 Del. Laws, c. 421, § 7; 59 Del. Laws, c. 106, § 8; 66 Del. Laws, c. 136, §§ 15, 16.;
§ 244 Reduction of capital.
(a) A corporation, by resolution of its board of directors, may reduce its capital in any of the following ways:
(1) By reducing or eliminating the capital represented by shares of capital stock which have been retired;
(2) By applying to an otherwise authorized purchase or redemption of outstanding shares of its capital stock some or all of the capital represented by the shares being purchased or redeemed, or any capital that has not been allocated to any particular class of its capital stock;
(3) By applying to an otherwise authorized conversion or exchange of outstanding shares of its capital stock some or all of the capital represented by the shares being converted or exchanged, or some or all of any capital that has not been allocated to any particular class of its capital stock, or both, to the extent that such capital in the aggregate exceeds the total aggregate par value or the stated capital of any previously unissued shares issuable upon such conversion or exchange; or
(4) By transferring to surplus (i) some or all of the capital not represented by any particular class of its capital stock; (ii) some or all of the capital represented by issued shares of its par value capital stock, which capital is in excess of the aggregate par value of such shares; or (iii) some of the capital represented by issued shares of its capital stock without par value.
(b) Notwithstanding the other provisions of this section, no reduction of capital shall be made or effected unless the assets of the corporation remaining after such reduction shall be sufficient to pay any debts of the corporation for which payment has not been otherwise provided. No reduction of capital shall release any liability of any stockholder whose shares have not been fully paid.
(c) [Repealed.]
8 Del. C. 1953, § 244; 56 Del. Laws, c. 50; 59 Del. Laws, c. 106, § 9; 64 Del. Laws, c. 112, §§ 25, 26.;
§ 245 Restated certificate of incorporation.
(a) A corporation may, whenever desired, integrate into a single instrument all of the provisions of its certificate of incorporation which are then in effect and operative as a result of there having theretofore been filed with the Secretary of State 1 or more certificates or other instruments pursuant to any of the sections referred to in § 104 of this title, and it may at the same time also further amend its certificate of incorporation by adopting a restated certificate of incorporation.
(b) If the restated certificate of incorporation merely restates and integrates but does not further amend the certificate of incorporation, as theretofore amended or supplemented by any instrument that was filed pursuant to any of the sections mentioned in § 104 of this title, it may be adopted by the board of directors without a vote of the stockholders, or it may be proposed by the directors and submitted by them to the stockholders for adoption, in which case the procedure and vote required, if any, by § 242 of this title for amendment of the certificate of incorporation shall be applicable. If the restated certificate of incorporation restates and integrates and also further amends in any respect the certificate of incorporation, as theretofore amended or supplemented, it shall be proposed by the directors and adopted by the stockholders in the manner and by the vote prescribed by § 242 of this title or, if the corporation has not received any payment for any of its stock, in the manner and by the vote prescribed by § 241 of this title.
(c) A restated certificate of incorporation shall be specifically designated as such in its heading. It shall state, either in its heading or in an introductory paragraph, the corporation's present name, and, if it has been changed, the name under which it was originally incorporated, and the date of filing of its original certificate of incorporation with the Secretary of State. A restated certificate shall also state that it was duly adopted in accordance with this section. If it was adopted by the board of directors without a vote of the stockholders (unless it was adopted pursuant to § 241 of this title or without a vote of members pursuant to § 242(b)(3) of this title), it shall state that it only restates and integrates and does not further amend the provisions of the corporation's certificate of incorporation as theretofore amended or supplemented, and that there is no discrepancy between those provisions and the provisions of the restated certificate. A restated certificate of incorporation may omit (a) such provisions of the original certificate of incorporation which named the incorporator or incorporators, the initial board of directors and the original subscribers for shares, and (b) such provisions contained in any amendment to the certificate of incorporation as were necessary to effect a change, exchange, reclassification, subdivision, combination or cancellation of stock, if such change, exchange, reclassification, subdivision, combination or cancellation has become effective. Any such omissions shall not be deemed a further amendment.
(d) A restated certificate of incorporation shall be executed, acknowledged and filed in accordance with § 103 of this title. Upon its filing with the Secretary of State, the original certificate of incorporation, as theretofore amended or supplemented, shall be superseded; thenceforth, the restated certificate of incorporation, including any further amendments or changes made thereby, shall be the certificate of incorporation of the corporation, but the original date of incorporation shall remain unchanged.
(e) Any amendment or change effected in connection with the restatement and integration of the certificate of incorporation shall be subject to any other provision of this chapter, not inconsistent with this section, which would apply if a separate certificate of amendment were filed to effect such amendment or change.
8 Del. C. 1953, § 245; 56 Del. Laws, c. 50; 56 Del. Laws, c. 186, § 15; 59 Del. Laws, c. 437, § 11; 64 Del. Laws, c. 112, §§ 27-29; 70 Del. Laws, c. 587, § 16; 73 Del. Laws, c. 82, § 13; 77 Del. Laws, c. 253, §§ 36, 37.;
§ 246 [Reserved.]
Logo Delaware Code Online
Sierra World Equity Review is a sham. It reminds me of the Bogart movie "The Treasure of Sierra Madre". Remember the famous lines. "We ain't got no badges. We don't need no badges. I don't have to show you any stinking badges." However, here the call from Sierra World Equity Review would be "I don't have to show you any stinking Investment Credentials". The bandit in the movie and the bandit behind the blog site are one and the same.
The chance of Pfizer buying this company is a joke. I hope no one seriously thinks this is a possibility.
Warning! Warning!You are getting played by a STOCK PROMOTION SCHEME if you are here looking for a legitimate investment. You are either being played by insiders to the scheme or getting played by the greater fool theory of trading. The hope is for you to be the bigger fool and end loser. The insiders to the scheme know in advance when the bogus PRs will come and when they will end. You don't. This company in undergoing massive stock dilution and can dilute to the tune of 10 Billion shares, which was done in violation of SEC laws. The SEC mandates a shareholders vote to expand the authorized shares. Ten Billion shares folks; expect a lot more stock giveaways and dilution.
ANATOMY OF A STOCK PROMOTION SCAM
Total of 58,089818 shares of stock given away or exchanged for debt since July 1, 2014!
This is an increase of 80% in the number of shares outstanding.
No funds were put aside for R & D activities.
About $30,000 was spent on R & D in the last 2 1/2 years.
$5000 of funds were "wired" to pay for this stock promotion scheme (more than 1/3 of available cash).
It takes about $1.2 Billion to take a biological product through Clinical Trials and FDA approval.
This company is not even conducting pre-clinical studies!
Only about 9% of new biologics that begin clinical trials make it to market.
The Chief Scientific Officer lives on the complete opposite side of the world and make his living practicing Holistic medicine.
What could possibly go wrong here?
Here is a good simple explanation of the NVAX RSV vaccine from YMB for those who don't want to navigate the horror show over there.
RSV unbeaten for decades. But, NVAX RSV vaccine is practically guaranteed.
by wily.coyote
Although RSV vaccine has been elusive for several decades, the difficulty is not in the virus itself. The RSV is closely related to the flu virus, and should be easily beaten. The problem was in the old approaches used, not the virus itself. The day a company called NVAX came up with a new method, RSV was beaten.
Briefly, the traditional methods of making vaccines consist of "farming" the virus, killing the resulting viruses, and then injecting the dead or weakened viruses in people. Then, the immune system learns how to produce antibodies against the virus. Since the viruses injected were inactivated or attenuated, the immune system can take its time to learn how to fight it. Later on, when the person contracts the real virus, the immune system is already "educated" in how to fight it. It will fight it and kill it before the person gets sick.
What made the RSV unbeatable was because the parts that the immune system needs to fight were simply not targeted by the immune system. Then, the only solution would be to force the immune system to target those parts. You could not do this with traditional technologies because all they could do is to create offsprings of the parent viruses with little difference from the parent virus.
How did NVAX solve the problem? NVAX realized that Synagis worked well against RSV, except that Synagis is incredibly expensive and has too many disadvantages to be used for cases other than very serious cases of newborns. What made Synagis work was the fact that it targets Site II of the fusion protein RSV-F. So, NVAX created a (nanoparticle) protein that mimics RSV-F, except for Site II, which NVAX made it more pronounced. NVAX could do this because their VLP/nanoparticle technology is capable of pruning/grafting RNA/DNA gene sequences in ways unbeatable by none.
To this date, only NVAX figured out how to do this. It was extremely difficult, but NVAX did it. Even if competitors succeeded in doing what NVAX did, they would remain a few years behind NVAX, especially since they cannot use the patented discoveries made by NVAX.
As you can see, the difficulty was in creating a "proper" protein to present to the immune system. Now that NVAX has done that, the RSV virus becomes just as easy/difficult to beat as flu viruses. Remember that in all past RSV clinical studies NVAX RSV vaccine induced the immune system to generate 5-10 times more Synagis-like antibodies than Synagis (5 for unadjuvanted, 10 for adjuvanted).
If you think about the above, you'll realize why the case with the (previously) unbeatable RSV is completely different from the cases of yet unbeatable diseases such as cancer. The risks to NVAX investors pale in comparison to the risks with any other company working on yet-unbeatable diseases.
The results of the upcoming RSV phase IIb and later H7N9 phase I/II are practically guaranteed to be just as OUTSTANDING as the results of previous clinical results.
Disclosure: More loaded with NVAX than any other investor, bar none (relative to net worth).
I heard a radio ad last Thursday at 3:00 P.M. in Boston for Nyloxin on WRKO. Has anyone else heard any radio ads?
Great YMB post from phama stock trader
I think some of you are missing the broader point here.
The seasonal candidate meeting the criteria for accelerated approval from the FDA is only part of the story. Don't miss the forest for the trees
The vaccine has the potential to fulfill the US Food and Drug Administration (FDA) Center for Biologics Evaluation and Research criteria for accelerated approval. The FDA grants accelerated approval to drugs that target an unmet medical need, or ones that are more beneficial than current treatments.
This trial is the first trial evaluating the company's quadrivalent seasonal influenza vaccine candidate produced using its single-use bioprocessing production system. This advanced manufacturing technology will be the basis for its commercial production of seasonal and pandemic influenza vaccines, as well as for the company's RSV and rabies vaccines.
The science has been validated, the trial results for their pipeline have been positive at every stage thus far and the largest unmet medical need worldwide is the elephant in the room we like to call RSV
A poster on YMB (wily.coyote) put in simple terms the reason the RSV Vaccine is a winner. I believe this has been the primary reason for the move in this stock for the last month. Bill
I know I've been hesitant to talk about $20 in the past few months. But, that was because I did not know how NVAX could solve the RSV problem when no one else could for decades.
With Dr. Glenn's presentation of yesterday, I finally learned the secret. NovaVax figured out how to induce the immune system to produce antibodies that concentrate on one particular site of the RSV fusion protein. They did that by developing an RSV VLP (i.e. mock RSV) that resembles the RSV in every way except for site II of the fusion protein. They included a much larger quantity of site II in the VLP than normally exist in the real RSV. Obviously, another difference is that they did not include the RNA in the RSV VLP (The RNA is what causes the virus to spread and overwhelm the patient).
Traditional tech could not possibly do that. They could not create RSV that has more copies of site II than normally exist in the fusion protein.
All traditional tech can do is to farm the RSV to produce a huge quantity of RSV, destroy the RNA, and then inject some of these inactivated viruses in a person. The inactivated viruses in the vaccine are exact copies of the mother RSV. No possible way (with traditional tech) to create them any different, unless they tinker with the RNA, thereby risking unintended consequences, or the creation of a virus that is much more lethal.
I'm telling you folks, the RSV vaccine is now much closer to success. I have never felt this good about it.
Three new patents recently published 11-Jul-12 08:25 am
1. (WO2012088428) MODIFIED INFLUENZA HEMAGGLUTININ PROTEINS AND USES THEREOF
2. (WO2012061815) RABIES GLYCOPROTEIN VIRUS-LIKE PARTICLES (VLPs)
3. (ES2380021) Partículas funcionales similares al virus (VLP) de la gripe
To get more info go to the following web site:
http://wipo.int/portal/index.html.en
Click on "Patent search" on the lower left side.
Enter Novavax in the "Front Page" field and click "Search"
Click on 2012 under the "Pub Date" column.
Three new patents recently published 11-Jul-12 08:25 am
1. (WO2012088428) MODIFIED INFLUENZA HEMAGGLUTININ PROTEINS AND USES THEREOF
2. (WO2012061815) RABIES GLYCOPROTEIN VIRUS-LIKE PARTICLES (VLPs)
3. (ES2380021) Partículas funcionales similares al virus (VLP) de la gripe
To get more info go to the following web site:
http://wipo.int/portal/index.html.en
Click on "Patent search" on the lower left side.
Enter Novavax in the "Front Page" field and click "Search"
Click on 2012 under the "Pub Date" column.
This is moving on very favorable RSV results. This will go much higher after it takes a breather.
Bill
Dawson James update. Target $4.50/share. http://www.dawsonjames.com/portal/NVAX_Update_3_1_11.pdf
Video of Governor's visit to Novavax. Have to love Dr. Singhvi's enthusiasm. http://rockville.patch.com/articles/video-omalley-tours-novavax#video-5179159
http://rockville.patch.com/articles/video-omalley-tours-novavax
The 2 news announcements created a gap from $2.65/shr. Most gaps get filled and the stock is trying to do that here. I had an order to buy more shares just above the gap, but it did not come close to filling. It is a cat and mouse game now. There is probably a short term demand for 20 million shares but everyone is waiting to see if the gap fills before they buy.
Bill
NOVAVAX Special Investor Conference Call and Webcast
Rockville, Maryland
March 1, 2011 10:00 am
Real time Dial-in: 1-877-212-6076 (domestic) or 1-707-287-9331 (international)
Replay dial-in: 1-800-642-1687 (domestic) or 1-706-645-9291 (international), conference ID: 48683057
Webcast: Click here.
http://www.novavax.com/go.cfm?do=Page.View&pid=36
Maybe tomorrow? It is $3.30 now.
Bill
HHS Awards Contracts to Develop New Flu Vaccine Technology
February 28, 2011: Two contracts support advanced development of next-generation recombinant vaccine. The U.S. Department of Health and Human Services (HHS) awarded two contracts today to help make vaccine available more quickly for seasonal flu outbreaks and pandemics. The contracts for advanced development of new types of vaccine and new ways to make flu vaccine known as next-generation recombinant influenza vaccine total $215 million.
“The 2009 H1N1 pandemic demonstrated the need for technologies that can provide vaccines more rapidly,” HHS Secretary Kathleen Sebelius said. “These next-generation flu vaccines hold the potential to be even more effective and to make the first and last doses of vaccine available sooner than existing flu vaccines by weeks and months which can save more lives during a pandemic as well as during seasonal flu outbreaks.”
HHS awarded one contract to Novavax, Inc., of Rockville, Md., for $97 million over the first three years, which can be extended for an additional two years, for a total contract value of $179.1 million. HHS awarded a separate contract to VaxInnate, Inc. of Cranbury, N.J., for $117.9 million over the first three years, which can be extended for two additional years, for a total contract value of $196.6 million.
Under its contract, Novavax is to develop new technology to produce vaccines using insect cells to express influenza proteins and create virus-like particles that stimulate a strong immune response in humans.
VaxInnate is developing a recombinant influenza vaccine technology based on combining influenza and bacteria proteins to stimulate strong immune response to protect against the flu.
Through these contracts, both companies will conduct clinical safety and efficacy studies and optimize and validate their manufacturing processes, which are needed to obtain licensing from FDA in order to use the new technologies in manufacturing flu vaccine in the United States.
These next-generation recombinant influenza vaccines were supported in early stages by the National Institutes of Health and will complement currently available and other new influenza vaccines. Today’s contracts for advanced development are supported by the HHS Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response.
The contracts are part of a national pandemic vaccine preparedness strategy, which includes the advanced development of new types influenza vaccines as well as expanding and diversifying domestic influenza vaccine production, and establishing and testing stockpiles of pre-pandemic vaccine. In addition, the recombinant flu vaccine may enhance pandemic vaccine manufacturing surge capacity in the United States.
The contracts use the federal government’s new approach to producing medical countermeasures – the medications, vaccines, medical equipment and supplies needed for a health emergency. On Aug. 19, HHS Secretary Kathleen Sebelius released an examination of the federal government’s system to produce medical countermeasures, along with recommendations for a better approach. The recommendations included developing flexible, robust, nimble and innovate technologies to increase capacity and produce vaccines for pandemic influenza and other threats in a much shorter timeframe. These recommendations were consistent with a report by the President’s Council of Advisors on Science and Technology, titled “Report to the President on Reengineering the Influenza Production Enterprise to Meet the Challenges of Pandemic Influenza.” Both reports are available at www.phe.gov/preparedness/mcm/enterprisereview/Pages/default.aspx.
BARDA provides a comprehensive, integrated, portfolio approach to the advanced research and development, innovation, acquisition, and manufacturing infrastructure for vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health emergency threats. These threats include chemical, biological, radiological, and nuclear threats, pandemic influenza, and emerging infectious diseases. For more information, visit www.phe.gov.
NEW YORK (AP) -- AT&T Inc. is expanding Wi-Fi access for its subscribers in New York and introducing it in San Francisco, adding data capacity in two cities with heavy wireless network use from the iPhone and other devices.
The phone company is to announce Tuesday that it will expand Wi-Fi hot spots in New York's Times Square just ahead of New Year's revelers cramming there for the annual countdown to midnight. It is also deploying its first hot spots in a public, outdoor area of San Francisco, the Embarcadero waterfront district.
For years, AT&T has operated a wide network of hot spots in hotels, airports, Starbucks coffee shops and other indoor locations. The new "hot zones," as AT&T calls them, are different in that they cover public, outdoor spaces are and cluster together many access points to cover a larger area.
The zones provide fast data service for AT&T subscribers and divert traffic from the company's cellular network. Many AT&T smart phones, including the iPhone, connect automatically to AT&T Wi-Fi when it's available.
IPhone users are legion in both New York and San Francisco and tax AT&T's network heavily. The company made it a priority this year to improve wireless service in the two cities.
The Dallas-based company set up a hot zone in Times Square in May, and later in downtown Charlotte, N.C., and Chicago's Wrigleyville neighborhood.
Chief Technology Officer John Donovan said those pilots have been successful, so the company is expanding coverage around Times Square and setting up zones around nearby Rockefeller Center and St. Patrick's Cathedral.
Donovan said the company plans further Wi-Fi expansions, including in sports stadiums.
Wi-Fi is a cost-effective complement to wireless broadband over AT&T's regular, 3G cellular network, Donovan said, but it doesn't replace investment in that technology. The motivation for the zones is to improve the subscriber experience where a lot of people gather, he said.
AT&T's smart-phone and landline broadband subscriber can use the zones for free, and usage doesn't count toward monthly data limits.
December 23, 2010, 11:25 AM GMT.Deals to Be Done After AstraZeneca Setback.The halt in development by AstraZeneca of its most advanced follow-up compound for respiratory syncytial virus (RSV) infection might spur interest in a handful of earlier-stage projects. Developing a vaccine for the disease remains a significant long-term goal for the biotech industry.
The discontinuation of motavizumab changes the playing field in this potentially lucrative disease area, and makes Alnylam Pharmaceuticals Inc. and Cubist Pharmaceuticals Inc.’s ALN-RSV01, currently in Phase II trials, the most advanced RSV therapy in development.
A successful outcome in the study would surely prompt Cubist to consider buying out its junior partner, and might even renew speculation about a larger company buying out Cubist. Much earlier in development, meanwhile, MicroDose Therapeutx Inc, Novavax Inc. and NanoBio Corp. — the last two working on vaccines — offer possible licensing opportunities.
Of course, any potential partner — or indeed acquirer — would need to look far ahead, given that research here is still at a very early stage. Moreover, AstraZeneca is still the undisputed leader in this space, and won’t give up this position easily.
The U.K. company sells Synagis, the only drug approved for prevention of RSV in high-risk infants. Despite having only moderate efficacy, Synagis generates around $1 billion of sales a year, and Nomura analysts expect this level to be maintained; it isn’t a fast-growing drug, but should generate steady revenue at least until its patents start to expire in 2018.
Motavizumab was being developed as a more effective follow-up to Synagis, and had completed clinical studies — hence the hefty $445 million write-off booked by AstraZeneca when it was canned. The company has additional projects in the pipeline, including another follow-up in Phase I, and two vaccines in Phase I/II studies.
Of interest to a rival company wanting a slice of the action could be currently unpartnered clinical-stage projects under way at MicroDose Therapeutx, a private U.S. firm, and Australia’s Biota, although the latter is looking to follow-on molecules after the failure of a lead in Phase Ia trials.
And while AstraZeneca leads in the vaccines space, don’t rule out the preclinical vaccines on which Novavax and NanoBio are working.
The first has just received clearance to start a Phase I trial, making it the only RSV vaccine except AstraZeneca’s to get it into the clinic. NanoBio, meanwhile, last month secured a $6 million development grant from the Bill and Melinda Gates Foundation, which should propel its vaccine toward human studies.
Expect companies like Novartis and Merck & Co. Inc., which have a history of work in this area, to keep an eye on the RSV vaccine space. Given the preclinical stage of development, either project could likely be licensed for a modest up-front payment and the promise of future milestones.
Sure, successfully developing an RSV vaccine will be no picnic, and many obstacles will lie in the way, as earlier thwarted attempts have shown. But the fact that RSV is the leading cause of childhood hospitalization, along with the possibility of using an approved drug or vaccine in the elderly and thus expanding the market, should underpin industry efforts to improve on Synagis.
This article originally appeared on Dow Jones Investment Banker. To find out more about the service please visit: www.dowjones.com/ib/
Copyright 2008 Dow Jones & Company, Inc. All Rights Reserved
The frustrating lack of news has been matched by the stability of current management. This makes me believe that management thinks that RSV Vaccine development and the RFP for Flu Vaccine development are progressing as expected. We shall see.
Bill
At a minimum we shold get an update on RSV Vaccine development.
There clearly has been value here. As much as shareholders could see it, prior management never wanted it to benefit shareholders. This could end up being a very improbable successful end to a long bloody road for shareholders. Good luck to everyone.
Bill
This stock over the years has had more twists and turns than a red-light district pole dancer. I hope this is not another one of those wild runs for naught where a lot of people lose a lot of money again. I got out at 93 cents and bought again in the pennies. Dave, if you are reading this board, please do not screw us investors as every other management team before you has done.
Bill
Dawson research report. http://www.dawsonjames.com/portal/NVAX_Initiation_15_June_2010.pdf
Patience is key here as I believe BARDA will be awarding the current RFP to them. The only question in my mind is when will it happen? HHS would not have wasted their time involving Novavax to put together the new Vaccine Initiatives only to leave them at the alter. The new initiatives mean more money and I think that BARDA will provide all the funding to get the Novavax Flu Vaccine Program all the way to the Vaccine Market. The delays have been frustrating, but I do believe that patience will be rewarded. Once BARDA is awarded I think we will see a lot more news about the RSV Vaccine Program.
Industry Embraces Review of Medical Countermeasures
by Mickey McCarter
Tuesday, 24 August 2010
HHS aims to speed up production, support early research
The scientific community and medical industry continue to react well to a review of the federal government's processes for producing medical countermeasures quickly in the face of a flu outbreak or bioterror attack.
The Biotechnology Industry Organization (BIO), an association representing more than 1,100 biotechnology companies and academic institutions in more than 30 nations, Friday applauded the release of the review by the Department of Health and Human Services (HHS) the previous day.
BIO CEO Jim Greenwood said in a statement, "We are pleased that the administration is highlighting this critical component of national security and believe this document is an important first step in focusing on the key issue of the development and procurement of medical countermeasures."
Greenwood said BIO looked forward to working with HHS and other organizations to implement the findings of the review and also to getting involved in discussions of other factors regarding emergency preparedness, like disease detection and surveillance and medical countermeasures distribution.
"We concur with HHS that the rapid detection of health threats and timely distribution of safe and effective medical countermeasures are pivotal to our nation's ability to respond to any biological threats," Greenwood said.
HHS Secretary Kathleen Sebelius released the results of the countermeasures review August 19--officially called the Public Health Emergency Medical Countermeasure Enterprise Review: Transforming the Enterprise to Meet Long Range National Needs.
The secretary vowed to spend $2 billion to implement the recommendations of the review, which centered on speeding up promising new research to produce effective vaccines and other countermeasures.
"Our nation must have a system that is nimble and flexible enough to produce medical countermeasures quickly in the face of any attack or threat, whether it's a threat we know about today or a new one," Sebelius said a statement last week. "By moving towards a 21st century countermeasures enterprise with a strong base of discovery, a clear regulatory pathway, and agile manufacturing, we will be able to respond faster and more effectively to public health threats."
Sebelius initiated the review after a slow start to the H1N1 swine flu vaccine production in 2009. The challenges in producing enough vaccine on schedule renewed concerns that the United States relies upon antiquated technologies for producing vaccines and medications, particularly in an emergency.
The review focused on five specific areas. First, it recommended boosting science and regulatory capacities at the Food and Drug Administration (FDA). As a result, Sebelius vowed to make a major investment in FDA resources to speed its ability to analyze new discoveries and provide regulatory approval to promising new medicines.
Second, HHS plans to release solicitations to support the Centers of Innovation for Advanced Development and Manufacturing as the review concluded that the United States should invest in manufacturing processes that result in the production of multiple medications instead of only one. The solicitations will call on industry to submit bids in support of upgrading the centers' capacity to manufacture multiple drugs, in part to avoid a reliance on foreign suppliers.
Third, to encourage breakthrough developments at small, emerging biotechnology companies, the Centers of Innovation for Advanced Development and Manufacturing will provide them with resources to bring new products to US markets and increase the amount of medications available for emergency situations.
Fourth, generally speaking, the government must foster more discoveries while they are in their early stages to ensure they reach maturity, the review noted. To support this concept, new teams at the National Institutes of Health will identify promising research and provide assistance with creating vaccines and other medications to protect the health of Americans.
Finally, HHS will assist small companies with finding investors to support niche drugs for which there is not a wide demand but which people may need in the event of a disease outbreak or biological attack.
Given that the review was sparked by challenges with meeting the initial deadlines for swine flu vaccine, it focuses particularly on flu response. The review called for an upgrade in flu vaccine manufacturing methods, ranging from means to test the strength of a vaccine to demonstrating that a vaccine is safe.
HHS would invest $2 billion on the five focus areas of the review in the next several years, Sebelius said.
The review supports the National Health Security Strategy, released by HHS last December, Sebelius emphasized in a speech in Washington, DC, August 19.
"The principle at the heart of that strategy is that our public health response is only as strong as its weakest link. So, using it as a guide, we've worked to upgrade our entire end-to-end response, from how we assess and identify threats to how we distribute and administer products to counter those threats in cities and towns across the country," she stated.
The strategy and the subsequent review fulfill a promise President Barack Obama made in his first state of the Union address last January by “launching a new initiative that will give us the capacity to respond faster and more effectively to bioterrorism or an infectious disease--a plan that will counter threats at home, and strengthen public health abroad," the review read.
Novavax Inc., a biotech company in Rockville, Md., working on faster new ways to produce vaccines for H1N1 and other health threats, was among the small companies embracing the results of the review last week.
"My colleagues at Novavax and I share the government's sense of urgency about accelerating the development and delivery of new vaccines to prevent the spread of infectious diseases as a result of a natural outbreak or a biological attack and have committed our company to the achievement of this goal," Novavax CEO Rahul Singhvi said in a statement August 19.
Singhvi stressed his belief that his company's recombinant technology could help speed up the production of critical vaccines, increasing their speed and supply to protect the health of the American public in the face of influenza outbreaks and other emergencies.
Many great scientists loath management responsibilities. Maybe that is the case here. Anyone close enough to the situation to elaborate?
Bill
Resignation of Paul Reid as our Director
On August 16, 2010, Paul Reid, our Director since April 10, 2008, resigned as a Director of our Board of Directors. Mr. Reid’s resignation as a Director was not regarding any matter pertaining to our operations, policies or practices. Mr. Reid will continue as Chief Executive Officer of ReceptoPharm, Inc., our wholly owned subsidiary that conducts drug research and discovery.
Anyone want to give a positive spin to this?
Bill
3 weeks ago I got a call from XCHO about reordering Cobroxin. I made my first order on line from XCHO and susequent purchases at Hannaford. Has anyone else gotten calls?
Bill
RSV NEWS OUT EOM 12 second(s) ago Novavax Reports Positive Results from Pre-Clinical Safety Study of Respiratory Syncytial Virus (RSV) Vaccine CandidateBY PR Newswire
— 8:00 AM ET 08/12/2010
ROCKVILLE, Md., Aug. 12 /PRNewswire-FirstCall/ -- Novavax, Inc. reported today that results from a pre-clinical toxicology study of its vaccine candidate to prevent respiratory syncytial virus (RSV), showed the vaccine to be safe and well-tolerated at all doses tested. Novavax's vaccine uses highly purified recombinant particles of RSV-F fusion (RSV-F) protein normally found in the virus. There is currently no approved vaccine to prevent RSV infection.
In previous animal studies, Novavax's vaccine candidate was well tolerated and protected against challenge with live RSV. In this safety study, rabbits were immunized with a placebo or the RSV-F vaccine at a dose of 3 or 30 micrograms with or without an aluminum phosphate adjuvant to boost immunogenicity. A placebo or vaccine was administered to each animal by intramuscular injection on days 1, 15 and 29. There were no vaccine-related adverse effects observed on any key measures of safety other than mild and temporary local reactions at the injection site.
Dr. Rahul Singhvi, President and CEO of Novavax (said, "We have now tested our RSV vaccine candidate in well-accepted animal models of toxicity and disease and found sufficient evidence of safety and effectiveness to advance our RSV vaccine candidate toward human clinical trials. The results of this formal safety study are consistent with our previous findings and provide identification of a safe dose for testing in a Phase I clinical study. We believe that these results, and our overall pre-clinical package, moves us one step closer to filing an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA)."
Calypso, if I remember correctly claimed that they did not appear in court because they were threatened with physical harm if they appeared. Does anyone remember this?
Bill
Earnings Release 1 minute ago NOVAVAX Reports Second Quarter 2010 Financial ResultsBY PR Newswire
— 8:00 AM ET 08/06/2010
ROCKVILLE, Md., Aug. 6 /PRNewswire-FirstCall/ -- Novavax, Inc. today announced financial results for the second quarter ended June 30, 2010.
Novavax reported a net loss of $9.4 million, or $0.09 per share, for the second quarter of 2010 compared to a net loss of $8.5 million, or $0.10 per share, for the second quarter of 2009. For the six months ended June 30, 2010, the net loss was $20.8 million, or $0.21 per share, compared to a net loss of $16.9 million, or $0.22 per share, for the same period in 2009. The primary reason for the increased loss for the second quarter of 2010 as compared to the same period in 2009 was higher research and development spending to support the company's clinical trials related to its H1N1 and seasonal influenza vaccine candidates, as well as increased general and administrative expenses relating to employee costs. Research and development expenses for the second quarter of 2010 were $6.3 million as compared to $5.3 million in the same period in 2009. General and administrative expenses were $3.1 million for the second quarter of 2010 as compared to $2.6 million in the same period in 2009.
As of June 30, 2010, the company had $26.8 million in cash, cash equivalents and short-term investments compared to $43.0 million as of December 31, 2009.
"Our financial results reflect the continued investment in Novavax 's vaccine candidates and prudent management of our financial and human resources," said Dr. Rahul Singhvi, President and CEO of Novavax "In addition to advancing our clinical programs, we are contending for a potentially significant vaccine development contract with the U.S. government, we have hired outstanding new executives to guide our clinical, pre-clinical and discovery programs, and we have fortified our patent portfolio."
Recent Accomplishments
Novavax recently reported the following corporate developments:
Receipt of notification from HHS/BARDA that a potential influenza vaccine development contract is in the "competitive range";
Achievement of positive results from trial of trivalent seasonal influenza vaccine in older adults;
Recruitment of new Chief Medical and Chief Scientific Officers and appointment of new Head of Process and Manufacturing Operations and Head of Analytical and Quality Operations;
Continued R&D progress in discovery of new targets to broaden vaccine pipeline;
Appointment of Dr. James Young, an accomplished and distinguished member of the biotech industry, to the Board of Directors;
Completion of construction of vaccine production facility in India by joint-venture company, CPL Biologicals; and
Receipt of key technology patent covering production of VLP vaccines from multiple strains of seasonal and pandemic influenza viruses.
Comments from Gale Smith are rare and this is probably a much bigger deal than people now realize. I think it also indicates a higher probability of success in scaling up to 1000L. This company is all about nano-engineering highly targeted vaccines and quickly making them in large commercial batches. A BARDA award is still a very likely event that, if awarded, should drive this stock to very high levels.
Bill
Warren Please continue to post. I want to see real feelings and reasoning expressed here, and if we feel it is wrong, we will answer it with a friendly discussion. The stock is dropping slowly and whatever you posted is probably in the minds of other investors. If it is not posted at all we will never address an appropriate response to people having identical concerns who don't like to post on the MB.
If this is not a successful stock I at the least hope the product survives in the marketplace. The Oral Spray has dramatically improved my wife's quality of life. I hardly ever hear her complain about her headaches and lower back pain. No one really talks about how convenient the oral spray is to take. You don't need water like you do with pills and it does not upset your stomach.
The company has performed like clockwork on every promise it has made. This is very rare in biotech land where lies and exagerations litter the landscape.
Bill
We are still in a very good position to get BARDA, maybe sometime this month. Lots of behind the scenes things are happening that point to an award.
Bill
Going down of fairly good volume.
Bill
Keep trying to apply several times a day and rub it in real well. If you are using for the first time it will take several days to start working. If you are trying to reach the painful area through thick muscle you will need the oral spay. My wife used the rub for her hips and it did not work, but the oral spay did give her relief. Good luck.
Bill
If this is not validation of the importance of this product, nothing is!
Bill