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CTI BioPharma Corp. Message Board

pharmainvestor1998 61 posts  |  Last Activity: Jan 30, 2015 10:46 AM Member since: Jun 23, 2010
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  • pharmainvestor1998 by pharmainvestor1998 Jan 30, 2015 10:46 AM Flag

    Their cash is dwindling and they are getting to the point where they will be living month-to-month off of how many shares they can dump in their ATM scheme with Maxim.

    Their press releases are rehashes of their old CFS and ebola pumps and are also giving the impression that HEB is running of fumes.

    There may be some financing deal in the works with Arrowhead BID, (the entity that just put out the cut-and-paste boilerplate "report" on HEB), but I doubt that it will be favorable to current retail investors, and at best it may only postpone the inevitable, (at worst it may hasten the end if toxic convertibles play any role).

  • pharmainvestor1998 pharmainvestor1998 Jan 26, 2015 11:46 AM Flag

    "ask them what happend with the white papers submission too !"

    Lol. They are probably lining a rat cage somewhere.

  • pharmainvestor1998 pharmainvestor1998 Jan 26, 2015 11:43 AM Flag

    "Now USAMRIID is spending millions more on Animal testing??"

    Although HEB's misleading press releases may be designed to lead you to such an erroneous conclusion, a close reading of the text reveals that there is no such additional spending.

  • Reply to

    NK-cells

    by pharmainvestor1998 Jan 26, 2015 10:48 AM
    pharmainvestor1998 pharmainvestor1998 Jan 26, 2015 11:41 AM Flag

    These modifications are as irrelevant as the "XMRV testing" modifications that HEB once made.

    And the fact that jonjonson/JohnnyD reads into such modifications evidence of FDA approval only displays his ignorance.

  • pharmainvestor1998 pharmainvestor1998 Jan 26, 2015 11:37 AM Flag

    The FDA gave no regard to open label studies such as Amp-511. They did note it for safety data, but only to note their alarm about how "there are apparent discrepancies in the
    data submitted by the Applicant in terms of the occurrence and severity of adverse
    event and laboratory abnormalities. In addition, there were apparent discrepancies in
    the Applicant’s coding of SAEs. The FDA audited the number of AEs leading to
    hospitalization and found the number of SAEs reported was less than would be
    expected from the database. "

  • Reply to

    NK-cells

    by pharmainvestor1998 Jan 26, 2015 10:48 AM
    pharmainvestor1998 pharmainvestor1998 Jan 26, 2015 11:35 AM Flag

    AMP-511 is an open-label trial that will remain irrelevant to the FDA's evaluation of Ampligen's efficacy. The FDA made clear in its briefing documents that it gives no regard to the Amp-511 study as an evaluation of Ampligen's efficacy. They did mention it in regards to Ampligen's safety, but only to describe how alarmed they were by HEB's miscoding and under-reporting of adverse events.

    HEB once heralded a modification to AMP-511 to include XMRV testing. Futility and hilarity ensued.

  • Reply to

    NK-cells

    by pharmainvestor1998 Jan 26, 2015 10:48 AM
    pharmainvestor1998 pharmainvestor1998 Jan 26, 2015 11:31 AM Flag

    "The facts are - Today - that the FDA has accepted NK cell function as a surrogate marker for CFS"

    The facts are - Today - that JohnnyD posted a total lie.

  • Reply to

    HEB has a long history of....

    by pharmainvestor1998 Jan 26, 2015 9:58 AM
    pharmainvestor1998 pharmainvestor1998 Jan 26, 2015 11:29 AM Flag

    Whether it is HIV, hepatitis, Ebola, SARS, CFS, West Nile Virus, Anthrax, cigarettes, SARS, you know that HEB will pump studies that lead to dead ends.

    Such has been the HEB story in the decades since Carter took over.

  • pharmainvestor1998 pharmainvestor1998 Jan 26, 2015 11:25 AM Flag

    There is no guarantee that HEB will break 0.63 cents in our lifetime.

  • Reply to

    This may be the best post you ever read here

    by jonjonsondd Jan 26, 2015 11:15 AM
    pharmainvestor1998 pharmainvestor1998 Jan 26, 2015 11:23 AM Flag

    That could very well be the most humorous post that I ever read here.

  • Reply to

    NK-cells

    by pharmainvestor1998 Jan 26, 2015 10:48 AM
    pharmainvestor1998 pharmainvestor1998 Jan 26, 2015 11:19 AM Flag

    "The facts are - Today - that the FDA has accepted NK cell function as a surrogate marker for CFS"

    Liar, liar, pants on fire...

  • pharmainvestor1998 by pharmainvestor1998 Jan 26, 2015 10:48 AM Flag

    Many pertubations of the immune system have been proposed as being a marker for CFS. NK-cells have been proposed for such a role since the 1980's (see below), along with various cytokine responses and other markers of the immune system. (e.g. HEB was once a big proponent of RNAse L as a marker). But, none have proven to be reliable, reproducible markers.

    I think that some misguided CFS patients have taken to posting their NK-cell counts as markers of their condition's disease activity. But, sadly, they are as misguided in this as they were in posting that they were "XMRV positive."

    "J Immunol. 1987 Nov 15;139(10):3306-13.

    Phenotypic and functional deficiency of natural killer cells in patients with chronic fatigue syndrome.

    Abstract

    Natural killer (NK)3 cells are large granular lymphocytes that appear to play a significant role in the host's defense against viral infection. We performed an extensive phenotypic and functional characterization of NK cells on 41 patients with the chronic fatigue syndrome (CFS),

  • Reply to

    Any Hope for this Stock?

    by krosenzweig Jan 26, 2015 10:25 AM
    pharmainvestor1998 pharmainvestor1998 Jan 26, 2015 10:32 AM Flag

    Even during the height of the pump of the doomed 2012 NDA, HEB's share price peaked at $1.

    Since then there has been heavy dilution. HEB has an at-the-market scheme with Maxim in which HEB has been dumping millions of shares per month. All of the HEB dumping will continue to smother the share price.

  • Reply to

    HEB has a long history of....

    by pharmainvestor1998 Jan 26, 2015 9:58 AM
    pharmainvestor1998 pharmainvestor1998 Jan 26, 2015 10:10 AM Flag

    "Hemispherx Reports Positive Independent Study Results of Alferon N in the Treatment of Pig Coronavirus (Animal Model of SARS)

    Philadelphia, PA, Monday, May 19, 2003: Philadelphia, PA, May 19, 2003 – Hemispherx Biopharma, Inc. (AMEX: HEB) reports the results of a “double-blinded” independent study conducted in a pig population suffering from the pig coronavirus, after therapeutic intervention with one of the Company’s lead Products, Alferon N. Newborn piglets, treated with Alferon N, even in low doses, had significantly greater survival rates than placebo-treated, control, piglets. Recent tests, May 14, 2003, at the Erasmus Medical Center, Amsterdam, confirm “the proof that a coronavirus is the primary cause of the disease” (human SARS) by fulfilling Koch’s Postulates thru the serial steps of coronavirus isolation (from man), reintroduction of virus and recreation of disease in macaque monkeys."

  • Reply to

    HEB has a long history of....

    by pharmainvestor1998 Jan 26, 2015 9:58 AM
    pharmainvestor1998 pharmainvestor1998 Jan 26, 2015 10:08 AM Flag

    Note how in 2003, they were trying to convince gullible investors that there were "New FDA Regulations" that would make it easy to get approved.

    Oh, yesireee, investors who fell for that one are surely living it up on Easy Street.

    "Hemispherx Biopharma: New NIH Sponsored Data on Ampligen presented
    with West Nile Virus

    Ampligen effective in reducing morbidity and mortality in two different animal studies
    New FDA Regulations may permit accelerated commercialization

    Philadelphia, PA, Thursday, May 08, 2003: Hemispherx Biopharma, Inc. (AMEX: HEB) announced today that at the 16th International Conference on Antiviral Research, scientists of the Institute for Antiviral Research of Utah State University presented data, funded by the National Institutes of Health (NIH) and National Institutes of Allergy and Infectious Diseases (NIAID), which evaluated the Company’s experimental agent Ampligen® against West Nile Virus (WNV) in two animal models.

    New FDA Regulations and Accelerated Approval based on Animal Studies

    On May 31, 2002, FDA published a final regulation in the Federal Register to allow appropriate studies in animals to provide substantial evidence of effectiveness of new drug products when intended for use in reducing or preventing toxicity of chemical, biological, radiological, or nuclear substances (67 Fed. Reg. 37988). The scope of the regulation includes drugs intended to ameliorate or prevent serious or life-threatening conditions caused by exposure to lethal or permanently disabling toxic biological substances. The main criteria for accepting animal studies as the sole evidence of a drug’s efficacy is the evidence that the drug’s effect is demonstrated in more than one animal species expected to react with a response predictive for humans."

  • Reply to

    HEB has a long history of....

    by pharmainvestor1998 Jan 26, 2015 9:58 AM
    pharmainvestor1998 pharmainvestor1998 Jan 26, 2015 10:01 AM Flag

    "Hemispherx Awarded U.S. Patent on Novel Fusion Inhibitor of HIV

    Philadelphia, PA, Wednesday, October 17, 2001: Hemispherx Biopharma, Inc. (AMEX: HEB; HEBws) announced issuance of a major new patent (US Appl. 09/445,559) for an orally bioavailable inhibitor of HIV. The compound, designated "Oragen™ conjugate 33", is a member of a new class of HIV inhibitors which are designed to stop viral replication by preventing HIV from fusing (or joining) adjacent target cells in the body.

    The new compound, licensed exclusively from Temple University (Philadelphia, PA), was created by the ingenious coupling of a commonly available vitamin - vitamin B6 (folic acid) - to a specific small molecular weight nucleic acid (NA) - like material. The resultant drug was thus created to bypass potentially destructive enzymes in the stomach and thereafter to efficiently enter target cells previously infected with HIV. Recombinant DNA methodology ("cloning") was utilized to pinpoint the novel HIV disease fighting substances (proteins) triggered by cell exposure to Oragen™ conjugate 33."

  • pharmainvestor1998 by pharmainvestor1998 Jan 26, 2015 9:58 AM Flag

    HEB has a long history of pumping in vitro studies that go nowhere.

    "HEMISPHERX BIOPHARMA REPORTS PUBLICATION SHOWING
    SUPERIOR ACTIVITY OF ALFERON AGAINST SARS

    Alferon Highest Activity Against SARS Among 19 Clinically Approved Compounds

    Philadelphia, PA, Monday, April 19, 2004: Hemispherx Biopharma, Inc. (AMEX: HEB) announced today that the results of an independent study, conducted by the Genome Institute of Singapore, have been publicized in “Emerging Infectious Diseases”, Vol. 10, No. 4, April 2004. The study, “Inhibition of SARS Coronavirus Infection In Vitro with Clinically Approved Antiviral Drugs” suggests that Hemispherx’ s lead drug, Alferon N Injection, tested among 19 clinically approved compounds from several major antiviral pharmacologic classes, exhibits the most potent antiviral activity in an in-vitro model of SARS-CoV infection and is a potential drug for in vivo research. Companies contributing approved products included Roche, Schering-Plough, GlaxoSmithKline, Serono, Merck, Schering AG, Novartis and AstraZeneca."

  • pharmainvestor1998 pharmainvestor1998 Jan 25, 2015 11:48 AM Flag

    And the clowns are pumping FDASIA again.

    The laughs never stop on this board.

  • pharmainvestor1998 pharmainvestor1998 Jan 24, 2015 12:56 PM Flag

    luc is right.

    It is the very same, very tired, very old script for CFS pumping.

  • In the FDA's words:

    "There are limitations in conclusions that can be drawn from the submitted safety data
    due to the quality and quantity of data. First, there are apparent discrepancies in the
    data submitted by the Applicant in terms of the occurrence and severity of adverse
    event and laboratory abnormalities. In addition, there were apparent discrepancies in
    the Applicant’s coding of SAEs. The FDA audited the number of AEs leading to
    hospitalization and found the number of SAEs reported was less than would be
    expected from the database. The Applicant was notified of these apparent
    discrepancies and provided an updated number of SAEs based on review of the data
    for Study AMP-511. Given these limitations in the quality of the data, it is difficult to
    draw conclusions regarding potential safety signals.

    The FDA reviewed and categorized information from all SAE narratives. This review
    identified nine potential safety concerns associated with Ampligen use including
    thrombosis, major cardiac events, malignancy, unusual ocular diagnoses (acute
    macular neuroretinopathy), infusion reactions, abdominal pain/liver function test
    abnormalities, psychiatric events, infections, and autoimmune disease. One patient
    exposed to Ampligen met the criteria for Hy’s law, which is used during clinical
    development to assess a drug’s potential of inducing severe liver injury. Importantly,
    this adverse event was not reported as serious by the Applicant, even though it appears
    that the case could have had severe consequences without medical intervention."

CTIC
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