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Hemispherx Biopharma, Inc. Message Board

  • jonjonson992 jonjonson992 Dec 20, 2012 7:20 PM Flag

    dont know how many times Ive said this...

    It isnt carter...

    It isnt amplligen...

    Its a patient population which is non homogenous....

    Its that simple....

    CDC is working on trying to id cfs subgoups...

    The fda says it is too.....

    SO is heb thru chronix...

    Until something changes there will be little reason to do drug development in cfs....

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    • Cannot agree with you more JJ. CFS diagnose process is an exclusion process. Any fatigue that cannot be linked to known problems and has lasted more than 6 months will be taken as CFS. That is why in US, there are 5 milion CFS patients. to be honest, these 5 million patients could be from 100 different illnesses.

      Thought FDA is going to loose the stringent requirements for both clinical and statistical evidence this time since the agency knows AMP cannot treat all the CFS patients. In the 2009 CRL, there was a request for another trial that covers the "targeted population". Aparently, FDA is not comfortable for approving the drug for CFS patients as it is defined today.

      Sold yesterday as a loss. Bought ALXA at $5.5. Hope I can break even after this weekend.

    • "Until something changes there will be little reason to do drug development in cfs"

      I happen to agree. No big Pharma or anyone else is going to waste their time on this.

      "To those with CFS, we decided to say No to the only drug we know that works for some because of the data set. but hang in there for 5 to 7 years until we find something else".

      Sincerely
      FDA.

    • On target as usual JJ. It's now an FDA,CDC problem. It will be REAL interesting to see what they come up with.

 
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