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BioCryst Pharmaceuticals, Inc. Message Board

  • maphere maphere Feb 12, 2013 10:25 AM Flag

    NIH study on Tamiflu

    NIH NEWS, Feb. 5, 2013

    Although oseltamivir has been approved for use in the United States since 1999, no studies have shown conclusively whether the drug significantly reduces the amount of virus produced (shed) by an infected person.

    Reduced shedding would likely lessen the chances of an infected person passing the virus to others. The oseltamivir trial will enroll a total of approximately 560 people at 31 locations in the United States, Argentina and Thailand. Enrollees must be between the ages of 18 and 65 years and have confirmed influenza virus infection but not be hospitalized or suffering from any other health conditions that would put them at risk of developing influenza complications.
    __________________

    One study examines whether treatment with a licensed influenza drug, oseltamivir, reduces the time that infected people continue to produce virus in the upper airway.

    A second tests whether a combination of three licensed flu antiviral drugs works better than oseltamivir alone in people with influenza who have chronic health conditions, such as heart or lung disease, that put them at greater risk of severe illness.

    The third tests whether treatment with plasma enriched with anti-influenza antibodies improves the condition of hospitalized influenza patients compared to standard antiviral treatment alone.

    SortNewest  |  Oldest  |  Most Replied Expand all replies
    • Maybe they're figuring out that the at-risk populations, and hospitalizations, are not responding well to an orally delivered antiviral, and that they (the health establishment/drug approval process) are putting those at-risk populations at higher risk, as demonstrated by the 9% P&I mortality in recent weeks, well above epidemic levels. Waiting for the ACIP meeting Feb. 21 to discuss the influenza situation in more detail, but it seems that "the flu season" is over messaging is to reassure a cynical public in the face of elderly and pediatric hospitalizations and deaths.

    • actually i find this to be pretty interesting. NIH taking the reigns and preforming tests that the FDA didn't ask roche to do.

      I wonder what or who compelled them to do this trial...

      did stoney make a once-in-a-lifetime presentation to HHS BARDA?

      hmmmm...

      oh no, here come the shorts to take us to 95 cents...

      it's all your fault map!

      • 1 Reply to huskys4u2
      • Needless to say Husky, this is an intriguing story. Even though it's not probable that P gets approved (at least for what the PH3 trial was set-up for) it does leave the medical field with questions then of the "real"benefit from the antivirals they've been using for more than a decade.

        Now they want to test T with an adjuvant. If it helps T why not P?

        I don't know the end to this story but HHS is sitting on the PH3 review data right now. BARDA's IPR meeting has been completed (the one that Robin Robinson discussed back in Nov.) and there's word on the street that both IV T and R are coming up for licensure consideration (unknown ETA).

        ...turn the page...

    • just maybe .. are you still calling for the "conditional approval"

      When is the next high level, clandestine Govt. meeting with Secret Squirrel ??

      What are you trying to do? Take the stock down to 50 cents all by yourself? Really.

 
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