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Home  /   Forum   /   BioPharma   /   HEB Memispherx

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HEB Memispherx

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61 Posts
Pagina: «« 1 2 3 4 »» | Laatste | Omlaag ↓
  2. [verwijderd] 26 mei 2009 16:09
    Tuurlijk wel.

    Moet niet gekker worden.

    Wel stijgende..................

    FDASponsored by: Set-Up 'FDA' E-Mail Alerts!

    Hemispherx (HEB) Discloses Possible FDA Delay Due To Scheduling Changes

    More News related to HEB
    Hemispherx (HEB) Discloses Possible FDA Delay Due To Scheduling Changes
    Hemispherx Biopharma Announces Possible Brief Delay in FDA Action On Ampligen(r) New Drug Application

    Hemispherx (HEB) Discloses Possible FDA Delay Due To Scheduling Changes

    May 26, 2009 9:19 AM EDT

    Hemispherx Biopharma, Inc. (NYSE: HEB) today announced that the FDA has advised the company that it may require up to 1-2 additional weeks to take action beyond the scheduled Prescription Drug User Fee Act action date of May 25, 2009 on the New Drug Application for Ampligen, a selective TLR3 modulator, for the management of Chronic Fatigue Syndrome.

    Reason for the possible delay was attributed by the Agency to certain staff scheduling changes which might (or might not) delay the report.

  3. welshterrier 5 26 mei 2009 20:50
    回答: 今天没人谈 heb 由 初学者001 于 2009-05-26 10:40:40

    copied from another board:

    Head of FDA is being forced to sell interest in Renaissance Technology hedge fund.

    online.wsj.com/article/SB124328188115...

    Renaissance has shares in HEB. If they issue an approval and Renaissance goes up then the new head of the FDA benefits.

    This makes perfect sense and is why they used the word staff changes at the FDA is the reason for the delay.
  4. [verwijderd] 27 mei 2009 16:15
    Nice.

    Vriendelijke groet.

    En maar blijven stijgen.







    The Sage Group Widens Strategic Role to Assist HemispherX Biopharma in Pandemic Influenza Initiatives as Pacific Rim/Japan Treatment/Prevention Programs Accelerate
    The Sage Group 27 May 2009 12:00:00 GMT

    CLINTON, N.J., May 27 /PRNewswire/ -- The Sage Group, a privately held international health care consulting group, announced today that HemispherX Biopharma has expanded the mandate for The Sage Group to include, in addition to the strategic partnering efforts related to Ampligen (an experimental immunotherapeutic) for Chronic Fatigue Syndrome*, additional partnering efforts related to Ampligen's use to increase the effectiveness of preventative pandemic flu vaccines and the additional role of Alferon LDO (an experimental therapeutic) for treating various types of pandemic flu.

    In particular, Sage is assisting HemispherX in its work with the Japanese government in the rapid development of a response strategy for pandemic flu. According to Time Magazine, the number of swine flu cases in Japan are escalating with surprising speed, and health officials are not sure why. The Japanese government on Wednesday, May 20, 2009 confirmed the first two cases of the disease in Tokyo, the world's most populous metropolitan area. Meanwhile, the number of Japanese who have contracted the new flu has more than doubled since May 18 from 130 to 279, a rate of increase that is "without a doubt" the highest in Asia, says Peter Cordingley, regional spokesman for the World Health Organization. "It's explosive."

    On Friday morning May 22, 2009, the government was expected to adopt a set of guidelines to fight the flu at the recently established Headquarters for Countermeasures Against Influenza A (H1N1) in Tokyo. The new guidelines will be a modification of an existing plan created to counter the more virulent H5N1 virus, known as avian flu.

    Yoshi Mizuta, President of Sage Japan, said, "The Japanese government remains concerned about pandemic flu outbreaks and continues to support initiatives such as Dr. Hasegawa's work (Japanese National Institute of Infectious Diseases) which uses Ampligen along with a vaccine to prevent avian flu as recently reported in the primate studies Dr. Hasegawa has conducted."

    The Sage Group also acted as an adviser to HemispherX in HemispherX's two recent rounds of PIPE (Private Investment in Public Entities) financings, with Rodman and Renshaw as Underwriter, for approximately $50 million (common shares plus attached warrants). These financings were conducted to generate additional capital to fund the final development and introduction of Ampligen, for Chronic Fatigue Syndrome, in the US market. Wayne Pambianchi, Executive Director of The Sage Group, said, "HemispherX's success in closing this important financing in this troubled financial market, is a clear reflection of the perceived importance of their Ampligen technology in a broad range of immunological applications."

    *HemispherX has already announced that it has been notified by the FDA that the FDA may require up to 1-2 additional weeks to take action beyond the scheduled Prescription Drug User Fee Act action date of May 25, 2009 on the New Drug Application for Ampligen(r) (Poly I Poly C12U), a selective TLR3 modulator, for the management of Chronic Fatigue Syndrome.

    About The Sage Group, Inc.

    Sage is a senior-level health care, international, technology oriented, strategy and transaction advisory firm formed in 1994. The principals of Sage are seven highly experienced healthcare executives, each of whom has substantial strategic, analytical and hands-on operating experience, as well as extensive backgrounds in licensing - in and out, corporate partnering and M&A. In addition, Sage's advisors and senior directors have extensive knowledge in the clinical, regulatory and product development disciplines. Sage's principals have played key leadership roles as founders/CEOs in a number of emerging biomedical companies and senior executives in multinational corporations. They have also played key consulting roles in corporate partnering/acquisition and licensing strategies of emerging and mid-sized companies. Sage has offices in the United States, European Union, and Far East. For more information please visit www.sagehealthcare.com.

    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(R) (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics, Ampligen(R) and Oragens. Ampligen(R) 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(R)). 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.

    Information contained in this news release other than historical information, should be considered forward-looking and is subject to various risk factors and uncertainties. For instance, the strategies and operations of Hemispherx involve risk of competition, changing market conditions, change in laws and regulations affecting these industries and numerous other factors discussed in this release and in the Company's filings with the Securities and Exchange Commission. Any specifically referenced investigational drugs and associated technologies of the Company (including Ampligen(R), Alferon LDO and Oragens) are experimental in nature and as such are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials with the referenced disorders. The forward-looking statements represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements. Clinical trials for other potential indications of the approved biologic Alferon N Injection(R) do not imply that the product will ever be specifically approved commercially for these other treatment indications; similarly, the completion of the NDA filing process with Ampligen(R) does not imply that the product will ever be approved commercially.

    SOURCE The Sage Group






  6. jurpsy 29 mei 2009 07:13
    Hemispherx's CFS Drug Is a Long Shot!!!!!

    www.thestreet.com/story/10506671/1/he...

    ........ I step back and look at the entire picture -- -the shifting Ampligen efficacy data, a 5-year-old phase III study that appears to have failed, no clear accounting of the drug's safety, wishy-washy explanations for a delay at the FDA -- and it raises too many red flags. Ask my opinion, and I'm happy to offer it: Ampligen will not be approved.
  7. welshterrier 5 29 mei 2009 09:07
    quote:

    jurpsy schreef:

    Hemispherx's CFS Drug Is a Long Shot!!!!!

    www.thestreet.com/story/10506671/1/he...

    ........ I step back and look at the entire picture -- -the shifting Ampligen efficacy data, a 5-year-old phase III study that appears to have failed, no clear accounting of the drug's safety, wishy-washy explanations for a delay at the FDA -- and it raises too many red flags. Ask my opinion, and I'm happy to offer it: Ampligen will not be approved.

    die vent had met Dendreon ook geen gelijk, zou naar 1,00 dalen en de volgende dag was het 20,--
    lees maar eens op Yahoo
  8. [verwijderd] 29 mei 2009 09:10
    quote:

    welshterrier schreef:

    [quote=jurpsy]
    Hemispherx's CFS Drug Is a Long Shot!!!!!

    www.thestreet.com/story/10506671/1/he...

    ........ I step back and look at the entire picture -- -the shifting Ampligen efficacy data, a 5-year-old phase III study that appears to have failed, no clear accounting of the drug's safety, wishy-washy explanations for a delay at the FDA -- and it raises too many red flags. Ask my opinion, and I'm happy to offer it: Ampligen will not be approved.

    [/quote]

    die vent had met Dendreon ook geen gelijk, zou naar 1,00 dalen en de volgende dag was het 20,--
    lees maar eens op Yahoo
    Hij heeft in het verleden ook wat problemen gehad met CELL. Ik geloof niks wat die vent zegt. Al is het wel allemaal goed onderbouwd.
  10. [verwijderd] 30 mei 2009 18:58
    CCtje met Dr. William Carter.

    Something big is coming on monday.

    Nah,nog meer winst? het moet niet gekker worden,maar ga er wel voor.

    "Something big"kan natuurlijk ook nog meer aandelen betekenen,zeg nooit nooit,maar ga voor iets met vogelgriep en een door de overheid beschikbaar gestelde one billion $ar,en goedkeuring kan natuurlijk ook,maar liever de dingen 1 voor 1.

    Vriendelijke groet.

    www.stockshaven.com/
  12. [verwijderd] 2 juni 2009 18:48
    Post Approval Hemispherx Ampligen PPS Evaluation

    June 2, 2009


    Much to the delight of Hemispherx BioPharma individual and institutional investors, a reader and follower of StocksHaven Investments has evaluated the Price Per Share potential should Ampligen see FDA approval within the coming weeks.

    The following article has been submitted by an investor under the name: Ace Spader

    The much anticipated FDA decision on the Hemispherx Biopharma, Inc. drug Ampligen has held a large audience of traders glued to their computers while tirelessly posting rants and raves in various trading forums across the web. Some of the most popular topics have included wild conspiracy theories surrounding the dilutions by the company and the delays by the FDA. Others have postulated about all of the potential uses of Ampligen in the future with a particular emphasis on the pandemic flu. Of all the topics seen on these boards there is one that continues to resurface multiple times every day.

    “How high will the HEB price per share go once Ampligen gets approved?”

    This topic differs from the others in that we can come up with a result that is backed by facts, logic, and conservative estimates rather than just pure speculation. Out of my own curiosity I decided to tackle this problem. I believe my results will prove to be right on the money. My analysis calculates an estimated pps for HEB in the weeks following FDA approval of Ampligen to treat CFS patients in the US. We cannot predict what other events will occur to cause the pps to go higher or lower in that time frame, so I will just focus on the impact of this individual event.

    The Formula:

    ((Total Customer Base * Annual Revenue Per Customer * Possible Market Penetration * Net Profit Margin) / Cost of Equity) / Number of Outstanding Shares = Expected PPS
    I performed some extensive research to come up with fair estimates based on real world information for each of the variables in the equation. I then scaled the variables to come up with a conservative estimate. This is not an exact science, and some of the values could be quite different from what I have decided to use. However, by making an effort to err on the conservative side I can reduce the effect of errors that might be introduced by potentially inflated numbers found in my research.

    The numbers found in my research:

    The generally accepted number of people suffering from CFS in the US is 4,000,000.
    Of those 4,000,000 about 20% are the cases that would be considered for treatment using Ampligen.
    In a recent survey of doctors over 50% said they would likely change their prescribed treatment for CFS once Ampligen was approved. I chose to use a more conservative estimate of 35%.
    The annual cost of Ampligen treatments is $14,400. I chose to use a much lower number $4,800 which is 33% of the known cost to account for potential economies of scale and to err on the conservative side.
    The number of outstanding shares at the time of my analysis was 110,670,341. This was taken from the most recent SEC filing.
    At the time of my analysis the average Beta for HEB was 0.87.
    The risk free rate is 0.0013. I used the 3 month T-bill rate found on Bloomberg.
    The market’s historical excess return rate is 0.067.
    I calculated the Cost of Equity using the CAPM formula: (Beta * Market’s Historical Excess Return Rate) + Risk Free Rate = Cost of Equity. I then doubled the result to once again err on the conservative side. The resulting calculated Cost of Equity was 0.12.
    The Variables:

    C: Total Customer Base = 4,000,000
    R: Annual Revenue Per Customer = 4,800
    P: Potential Market Penetration = (20% * 35%) = 0.07
    N: Net Profit Margin = 0.15
    E: Cost of Equity = 0.12
    S: Number of Shares = 110,670,341
    The Equation:

    ((C * R * P * N) / E) / S
    ((4,000,000 * 4,800 * 0.07 * 0.15) / 0.12) / 110,670,341 = $15.18
    The Results:

    A conservative estimate for the PPS of HEB shortly after news that Ampligen has been approved by the FDA is $15.

    The Sanity Check:

    One could argue that there is simply too much room for error for this result to be meaningful. After All I did make choices to scale some of the numbers found in my research in order to come up with a more conservative estimate. And, the raw numbers found in my research might also be flawed. For these reasons I decided to perform an additional analysis to come up with a range to account for estimation errors.

    I applied the same formula to VNDA and TTNP using data from before the FDA approval of the drug Fanapt in order to gauge how accurate my estimate might be. The common business realities between Vanda Pharmaceuticals (VNDA) and Titan Pharmaceuticals (TTNP) allow me to apply the equation to both stocks using mostly the same values for key variables in the equation. This allows me to treat the common variables as constants thereby reducing variances caused by erroneous estimates. In simple terms by having less variables to adjust between the two calculations a more meaningful variance can be found. As it turns out there are only two variables that have different values between the VNDA calculation and the TTNP calculation, and one of those variables is the number of shares which has no room for error since it is a known number.

    VNDA Calculations:

    C: Total Customer Base = 2,000,000
    R: Annual Revenue Per Customer = 7,900 (Market is 15.8 billion in US / 2 million customers = 7,900)
    P: Potential Market Penetration = 0.028 (Competing with 6 other drugs. Target customer base = 14%. [0.14 * 0.2 = 0.028])
    N: Net Profit Margin = 0.15
    E: Cost of Equity = 0.24 (Beta for both VNDA and TTNP was roughly double the Beta of HEB before the approval of Fanapt.)
    S: Number of Shares = 26,650,000
    Predicted PPS = ((2,000,000 * 7,900 * 0.028 * 0.15) / 0.24) / 26,650,000 = 10.38

    Known post approval peak PPS = 14.79

    Difference between peak PPS and predicted PPS = 14.79 - 10.38 = 4.41

    Deviation from predicted pps = 4.41 / 10.38 = 42%

    TTNP Calculations:

    C: Total Customer Base = 2,000,000
    R: Annual Revenue Per Customer = 7,900
    P: Potential Market Penetration = 0.028
    N: Net Profit Margin = 0.08 (This number was disclosed.)
    E: Cost of Equity = 0.24
    S: Number of Shares = 58,290,000
    Predicted PPS = ((2,000,000 * 7,900 * 0.028 * 0.08) / 0.24) / 58,290,000 = 2.53

    Known post approval peak PPS = 1.70

    Difference between peak PPS and predicted PPS = 2.53 -1.70 = 0.83

    Deviation from predicted pps = 0.83 / 2.53 = 33%

    The Results:

    The average percentage deviation from the predicted pps is (42+33)/2 = 37.5%. Using this information I can now apply a range of roughly plus or minus 40% to my HEB predicted pps of 15.

    Lower limit = 15 * 0.6 = 9
    Upper limit = 15 * 1.4 = 21

    In Closing:

    My analysis shows that the PPS for HEB will peak somewhere between $9 and $21 within the first few weeks after FDA approval of Ampligen for treatment of CFS has been announced.
    I believe my analysis is very conservative, so I would not be surprised to see the PPS reach the upper limit of my range. And, if any other positive news comes out for HEB it could go beyond my calculated range later this year. I will be setting my sell limits very high, and I am long on HEB. I hope you all enjoyed reviewing this analysis, and hopefully you will find this method useful for other stocks in the future.

    Best Wishes,

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