arrow5 Comments
  1. Anne
    Dec 29 - 8:02 pm

    Yay, the Buzz is back! Thanks, Cort.

    A question on the Ampligen votes: I don’t quite get the difference between these two votes/questions. How can more committee members think the safety profile is adequate than think safety has been adequately assessed?

    – Has safety been adequately assessed? – No: 9; Yes: 4

    – Is the safety profile adequate for approval? – No: 5; Yes: 8

    (see the votes at: http://www.research1st.com/2012/12/27/fda-panel-votes/ )

    • Cort Johnson
      Dec 29 - 8:30 pm

      I love that Kim got all the votes up there….From what I’ve heard its a very unusual set of questions…I think it came down to the fact that people with ME/CFS are so in need that 8 of the commmittee members (but again not Dr. Komaroff, which I just cannot get over :)) felt that even if safety was not proven to the FDA’s standards, it was proven enough to give the drug to patients…

      I think that does leave Hemispherx and the FDA an opening…to conditionally approve the drug, limit the type of patients that can get it and then do more studies. Hopefully that’s what will happen.

  2. Hi Cort,

    Thanks for sharing the buzz about my site, CFS Recovery Project!

    I also also appreciate the other info you shared in the buzz. I admire how much information you’re able to comprehend, distill it down to the essentials, and share with the CFS community.

    Cheers,
    Johannes

    • Cort Johnson
      Dec 31 - 2:25 am

      Thanks Johannes…I’m looking forward to learning more techniques and watching your site evolve. Good luck with everything..

  3. Sasha
    Jan 05 - 7:43 am

    Thanks for this – particularly looking forward to reading more about the FDA decision on Ampligen.

    I tried to access Mindy Kitei’s article on that via the link provided but can’t get to cfscentral at all – it appears to require an invitation from Mindy via some sort of Google/blogger thing.

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