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SIGA Technologies, Inc. Message Board

  • hosaquavas hosaquavas Nov 26, 2013 9:50 AM Flag

    fast track FDA on ST246

    This is not even talked about by SIGA anymore, I understand the lawsuit and Rose thinking he is a secret agent but I thought this was waiting on FDA approval several years ago. Anyone have any updates on this.

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    • Just think what it would be if We were Slow Tracked....

      Sentiment: Hold

    • The FDA is the holdup. Ordinarily, fast tracked would have gotten us there by now - I think we got the designation in 2006. But since testing this drug for curing smallpox in humans is not something that can be done in any phase of testing, this is the first drug they are needing to approve under "animal rules". Like everything else the Feds do, they haven't been able to figure out what they will accept. SIGA has already done tons of safety studies, but I believe the FDA wants another larger group safety study. I believe once they do the NDA all the ducks will be lined up and approval will come quickly. Guessing late 2015.

    • Haven't you been paying attention?!? There's a new "buzz word"....they're OPTIMIZING the approval process!!

 
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